Trial Outcomes & Findings for SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (NCT NCT04722250)
NCT ID: NCT04722250
Last Updated: 2026-02-11
Results Overview
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1103 participants
Primary outcome timeframe
12 months
Results posted on
2026-02-11
Participant Flow
A total of 1103 subjects were enrolled (consented): 212 subjects were exited prior to screening,154 exited the study prior to randomization, 737\* subjects were randomized. \*Notes: One additional subject was inadvertently randomized but was withdrawn after screening disapproval. -716 subjects had an attempted procedure, these subjects are the As-Treated set and are analyzed according to their first attempted device. This includes both administrative and procedural crossovers as shown below.
Participant milestones
| Measure |
Medtronic Self-Expanding TAV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Overall Study
STARTED
|
366
|
371
|
|
Overall Study
Exited Prior to Procedure
|
10
|
11
|
|
Overall Study
ITT (Intention to Treat) Population After Exit Prior to Procedure
|
356
|
360
|
|
Overall Study
Administrative Cross-overs
|
2
|
1
|
|
Overall Study
Attempted With Randomized Device
|
354
|
359
|
|
Overall Study
Procedural Cross-overs
|
4
|
0
|
|
Overall Study
COMPLETED
|
350
|
359
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Baseline characteristics by cohort
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
Total
n=716 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.1 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
80.3 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
80.2 years
STANDARD_DEVIATION 6.2 • n=8 Participants
|
|
Sex/Gender, Customized
Gender Female
|
312 Participants
n=4 Participants
|
309 Participants
n=4 Participants
|
621 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Gender Male
|
43 Participants
n=4 Participants
|
52 Participants
n=4 Participants
|
95 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of US Only, Unknown number also includes outside of US. · Hispanic or Latino
|
4 Participants
n=4 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of US Only, Unknown number also includes outside of US. · Not Hispanic or Latino
|
171 Participants
n=4 Participants
|
174 Participants
n=4 Participants
|
345 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity of US Only, Unknown number also includes outside of US. · Unknown or Not Reported
|
180 Participants
n=4 Participants
|
182 Participants
n=4 Participants
|
362 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=4 Participants
|
165 Participants
n=4 Participants
|
326 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
182 Participants
n=4 Participants
|
182 Participants
n=4 Participants
|
364 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
183 Participants
n=4 Participants
|
184 Participants
n=4 Participants
|
367 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
18 Participants
n=4 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=8 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
Portugal
|
4 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=4 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
34 Participants
n=4 Participants
|
41 Participants
n=4 Participants
|
75 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
Finland
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
3 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
18 Participants
n=4 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
6 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=8 Participants
|
|
Region of Enrollment
France
|
16 Participants
n=4 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
59 Participants
n=4 Participants
|
57 Participants
n=4 Participants
|
116 Participants
n=8 Participants
|
|
Body Surface Area
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=8 Participants
|
|
STS Score
|
3.3 Percent
STANDARD_DEVIATION 1.9 • n=4 Participants
|
3.2 Percent
STANDARD_DEVIATION 1.7 • n=4 Participants
|
3.3 Percent
STANDARD_DEVIATION 1.8 • n=8 Participants
|
|
STS Category
Count of Participants
|
355 Participants
n=4 Participants
|
361 Participants
n=4 Participants
|
716 Participants
n=8 Participants
|
|
STS Category
<3
|
182 Participants
n=4 Participants
|
191 Participants
n=4 Participants
|
373 Participants
n=8 Participants
|
|
STS Category
[3,5)
|
122 Participants
n=4 Participants
|
123 Participants
n=4 Participants
|
245 Participants
n=8 Participants
|
|
STS Category
[5,8)
|
37 Participants
n=4 Participants
|
35 Participants
n=4 Participants
|
72 Participants
n=8 Participants
|
|
STS Category
≥ 8
|
14 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
26 Participants
n=8 Participants
|
|
NYHA (Baseline)
NYHA I
|
4 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=8 Participants
|
|
NYHA (Baseline)
NYHA II
|
197 Participants
n=4 Participants
|
211 Participants
n=4 Participants
|
408 Participants
n=8 Participants
|
|
NYHA (Baseline)
NYHA III
|
150 Participants
n=4 Participants
|
144 Participants
n=4 Participants
|
294 Participants
n=8 Participants
|
|
NYHA (Baseline)
NYHA IV
|
4 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Mortality, Disabling Stroke or Heart Failure Rehospitalization
|
9.7 Percent of Participants (K-M Rate)
|
10.6 Percent of Participants (K-M Rate)
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted). \*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.
Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=350 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=365 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Bioprosthetic Valve Dysfunction (BVD)
|
9.4 Percent of Participants (K-M Rate)
|
42.3 Percent of Participants (K-M Rate)
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) \*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.
Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)).
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=307 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=313 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Percentage of Participants With BVD in Female Subjects
|
8.4 percentage of participants (K-M rate)
|
42.7 percentage of participants (K-M rate)
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) \*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.
HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=350 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=365 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)
|
3.2 percentage of participants (K-M rate)
|
33.0 percentage of participants (K-M rate)
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
Mean aortic gradient as measured by echocardiogram at the 12-month visit.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=298 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=301 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Hemodynamic Mean Gradient as Continuous Variable
|
7.7 mmHg
Standard Deviation 4.0
|
15.7 mmHg
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=267 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=266 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Effective Orifice Area (EOA) as a Continuous Variable
|
1.98 cm2
Standard Deviation 0.47
|
1.50 cm2
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
Moderate or severe PPM will be defined as follows: For subjects with BMI \< 30 kg/m2 * Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2 * Severe PPM: EOAI = ≤ 0.65 cm2/m2 For subjects with BMI ≥ 30 kg/m2 * Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2 * Severe PPM: EOAI = ≤ 0.55 cm2/m2
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=273 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=296 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)
|
28 Participants
|
104 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Device Success is defined as meeting all of the following: Freedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s) AND No moderate or severe prosthetic valve regurgitation)
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=291 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=319 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Device Success
|
248 Participants
|
189 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Incidence of an early safety composite at 30 days defined as: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Incidence of an Early Safety Composite
|
9.9 percentage of participants (K-M rate)
|
7.2 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Hospital Readmission Rate for Any Cause
|
8.6 percentage of participants (K-M rate)
|
11.2 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
Incidence of clinical efficacy (after 30 days) at 12 months defined as a composite of: * All-cause mortality * All stroke (disabling and non-disabling) * Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure * NYHA class III or IV * Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) \<0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=288 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=224 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Incidence of Clinical Efficacy
|
12.5 percentage of participants (K-M rate)
|
31.5 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months and 2 YearsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
All Cause Mortality: 12 Months
|
5.1 percentage of participants (K-M rate)
|
5.9 percentage of participants (K-M rate)
|
|
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
Disabling Stroke: 12 Months
|
3.1 percentage of participants (K-M rate)
|
2.6 percentage of participants (K-M rate)
|
|
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
Heart Failure Rehospitalization: 12 Months
|
4.1 percentage of participants (K-M rate)
|
3.5 percentage of participants (K-M rate)
|
|
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
All Cause Mortality: 2 Years
|
12.7 percentage of participants (K-M rate)
|
11.4 percentage of participants (K-M rate)
|
|
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
Disabling Stroke: 2 Years
|
4.7 percentage of participants (K-M rate)
|
3.2 percentage of participants (K-M rate)
|
|
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
Heart Failure Rehospitalization: 2 Years
|
6.1 percentage of participants (K-M rate)
|
6.0 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 12 Months, 2 YearsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Note: This section is excluding subjects with pacemaker or ICD at baseline.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=325 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=336 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
New Pacemaker Implantation Rate
30 Days
|
12.1 percentage of participants (K-M rate)
|
7.8 percentage of participants (K-M rate)
|
|
New Pacemaker Implantation Rate
12 Months
|
14.0 percentage of participants (K-M rate)
|
9.3 percentage of participants (K-M rate)
|
|
New Pacemaker Implantation Rate
2 Years
|
15.4 percentage of participants (K-M rate)
|
11.4 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 12 months, 2 YearsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Aortic valve re-intervention rate as measured as the percentage of patients that had a procedure to fix or replace their prosthetic valve at the 30 days, 12 months and 2 Year visit.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Aortic Valve Re-intervention Rate
2 Years
|
0.9 percentage of participants (K-M rate)
|
0.9 percentage of participants (K-M rate)
|
|
Aortic Valve Re-intervention Rate
30 Days
|
0.6 percentage of participants (K-M rate)
|
0.3 percentage of participants (K-M rate)
|
|
Aortic Valve Re-intervention Rate
12 Months
|
0.9 percentage of participants (K-M rate)
|
0.6 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 12 Months and 2 YearsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
6-minute Walk Test (6MWT) Change From Baseline
30 Days
|
25.5 Meters
Standard Deviation 97.3
|
38.1 Meters
Standard Deviation 86.7
|
|
6-minute Walk Test (6MWT) Change From Baseline
12 Months
|
39.5 Meters
Standard Deviation 100.5
|
33.8 Meters
Standard Deviation 94.8
|
|
6-minute Walk Test (6MWT) Change From Baseline
2 Years
|
29.5 Meters
Standard Deviation 100.2
|
37.0 Meters
Standard Deviation 90.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 12 Months and 2 YearsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
30 Days: EQ5D Index
|
0.04 score on a scale
Standard Deviation 0.15
|
0.05 score on a scale
Standard Deviation 0.15
|
|
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
30 Days: EQ5D VAS
|
8.1 score on a scale
Standard Deviation 19.1
|
9.6 score on a scale
Standard Deviation 19.7
|
|
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
12 Months: EQ5D Index
|
0.04 score on a scale
Standard Deviation 0.15
|
0.02 score on a scale
Standard Deviation 0.15
|
|
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
12 Months: EQ5D VAS
|
8.4 score on a scale
Standard Deviation 20.1
|
7.6 score on a scale
Standard Deviation 19.4
|
|
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
2 Years: EQ5D Index
|
0.03 score on a scale
Standard Deviation 0.15
|
0.02 score on a scale
Standard Deviation 0.17
|
|
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
2 Years: EQ5D VAS
|
8.2 score on a scale
Standard Deviation 19.8
|
7.9 score on a scale
Standard Deviation 19.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 12 Months and 2 YearsPopulation: As Treated set (all subjects with attempted TAVR procedure according to first device used)
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Note: This is the overall summary score for KCCQ.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=355 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=361 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]
12 Months
|
20.3 score on a scale
Standard Deviation 20.3
|
17.6 score on a scale
Standard Deviation 19.4
|
|
Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]
30 Days
|
18.0 score on a scale
Standard Deviation 19.4
|
17.7 score on a scale
Standard Deviation 19.6
|
|
Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]
2 Years
|
19.3 score on a scale
Standard Deviation 20.1
|
17.3 score on a scale
Standard Deviation 20.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 YearsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).
Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=350 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=365 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Bioprosthetic Valve Dysfunction (BVD)
|
12.5 percentage of participants (K-M rate)
|
48.4 percentage of participants (K-M rate)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge, 30 Days, 12 Months and 2 YearsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).
Effective Orifice Area (EOA) as measured by echocardiogram at the following intervals: Discharge, 30 Days, 12 Months and 2 Years
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=350 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=365 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Effective Orifice Area (EOA) as a Continuous Variable
Discharge
|
1.96 cm^2
Standard Deviation 0.43
|
1.63 cm^2
Standard Deviation 0.36
|
|
Effective Orifice Area (EOA) as a Continuous Variable
30 Days
|
2.00 cm^2
Standard Deviation 0.46
|
1.52 cm^2
Standard Deviation 0.32
|
|
Effective Orifice Area (EOA) as a Continuous Variable
12 Months
|
1.98 cm^2
Standard Deviation 0.47
|
1.50 cm^2
Standard Deviation 0.35
|
|
Effective Orifice Area (EOA) as a Continuous Variable
2 Years
|
1.93 cm^2
Standard Deviation 0.48
|
1.51 cm^2
Standard Deviation 0.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge, 30 Days, 12 Months and 2 YearsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).
Mean aortic gradient as measured by echocardiogram at the following intervals: Discharge, 30 Days, 12 Months and 2 Years
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=350 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=365 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Hemodynamic Mean Gradient as a Continuous Variable
Discharge
|
8.1 mmHg
Standard Deviation 3.7
|
14.8 mmHg
Standard Deviation 5.4
|
|
Hemodynamic Mean Gradient as a Continuous Variable
30 Days
|
7.0 mmHg
Standard Deviation 3.1
|
14.4 mmHg
Standard Deviation 5.3
|
|
Hemodynamic Mean Gradient as a Continuous Variable
12 Months
|
7.7 mmHg
Standard Deviation 4.0
|
15.7 mmHg
Standard Deviation 6.7
|
|
Hemodynamic Mean Gradient as a Continuous Variable
2 Years
|
8.5 mmHg
Standard Deviation 4.2
|
16.1 mmHg
Standard Deviation 6.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Discharge, 30 Days, 12 Months and 2 YearsPopulation: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted).
Paravalvular Leak as measured by the percentage of participants that had none, trace, mild, moderate and severe, at Discharge, 30 Days, 12 Months and 2 Years
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=350 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=365 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
Discharge: PVL - Trace
|
43.9 percentage of participants
|
28.9 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
Discharge: PVL - Mild
|
12.2 percentage of participants
|
5.2 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
Discharge: PVL - Moderate
|
0.6 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
Discharge: PVL - Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
30 Days: PVL - None
|
36.7 percentage of participants
|
54.9 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
30 Days: PVL - Trace
|
46.0 percentage of participants
|
32.5 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
30 Days: PVL - Mild
|
17.0 percentage of participants
|
12.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
30 Days: PVL - Moderate
|
0.3 percentage of participants
|
0.6 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
30 Days: PVL - Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
12 Months: PVL - None
|
55.2 percentage of participants
|
64.9 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
12 Months: PVL - Trace
|
30.6 percentage of participants
|
15.5 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
12 Months: PVL - Mild
|
14.1 percentage of participants
|
18.6 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
12 Months: PVL - Moderate
|
0.0 percentage of participants
|
1.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
2 Years: PVL - None
|
56.8 percentage of participants
|
63.1 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
2 Years: PVL - Trace
|
27.6 percentage of participants
|
18.8 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
2 Years: PVL - Mild
|
14.8 percentage of participants
|
16.1 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
2 Years: PVL - Moderate
|
0.8 percentage of participants
|
2.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
2 Years: PVL - Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
12 Months: PVL - Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Paravalvular Leak (PVL) by Degree of Severity
Discharge: PVL - None
|
43.3 percentage of participants
|
65.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsMean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.
Outcome measures
| Measure |
Medtronic Self-Expanding TAV
n=29 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
|
Edwards Balloon-Expandable THV
n=33 Participants
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
|
|---|---|---|
|
Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram
|
2 Participants
|
14 Participants
|
Adverse Events
Attempted Medtronic Self-Expanding TAV (As Treated Set)
Serious events: 210 serious events
Other events: 0 other events
Deaths: 43 deaths
Attempted Edwards Balloon-Expandable THV (As Treated Set)
Serious events: 207 serious events
Other events: 0 other events
Deaths: 40 deaths
Attempted Both Devices
Serious events: 4 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Attempted Medtronic Self-Expanding TAV (As Treated Set)
n=355 participants at risk
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
\*\*Note: As Treated set (all subjects with attempted TAVR procedure according to first device used)
|
Attempted Edwards Balloon-Expandable THV (As Treated Set)
n=361 participants at risk
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
\*\*Note: As Treated set (all subjects with attempted TAVR procedure according to first device used)
|
Attempted Both Devices
n=4 participants at risk
This arm contains subjects that had a procedural cross-over (i.e., subjects who were first attempted with one device (per randomization assignment) and implanted with the other device at the time of the index TAVR procedure).
These subjects are analyzed with the other treatment device in the implanted set.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Sudden cardiac death
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Acquired left ventricle outflow tract obstruction
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Acute left ventricular failure
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Acute myocardial infarction
|
3.1%
11/355 • Number of events 11 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
2.2%
8/361 • Number of events 8 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Angina pectoris
|
0.85%
3/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Angina unstable
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Aortic valve incompetence
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Arrhythmia
|
0.56%
2/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrial fibrillation
|
7.6%
27/355 • Number of events 28 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
8.0%
29/361 • Number of events 41 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrial flutter
|
1.1%
4/355 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrial thrombosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrioventricular block
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrioventricular block complete
|
9.0%
32/355 • Number of events 34 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
4.7%
17/361 • Number of events 17 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Bundle branch block left
|
4.8%
17/355 • Number of events 17 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
4.2%
15/361 • Number of events 15 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Bundle branch block right
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiac arrest
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiac failure
|
2.5%
9/355 • Number of events 12 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
4.2%
15/361 • Number of events 17 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiac failure acute
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiac failure congestive
|
3.4%
12/355 • Number of events 16 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
2.8%
10/361 • Number of events 12 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiogenic shock
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Conduction disorder
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Coronary artery disease
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Coronary artery occlusion
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Coronary artery stenosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Intracardiac thrombus
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Mitral valve disease
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Mitral valve incompetence
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Mitral valve stenosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Nodal arrhythmia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Palpitations
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
5/355 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Pericarditis
|
0.28%
1/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Pulseless electrical activity
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Sinus bradycardia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Sinus node dysfunction
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Tachycardia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Trifascicular block
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Ventricular dyssynchrony
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Cataract
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Corneal disorder
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Macular degeneration
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Macular oedema
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Retinal artery occlusion
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Eye disorders
Visual impairment
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Adverse drug reaction
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Asthenia
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Chest pain
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Death
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.7%
6/361 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Device embolisation
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Gait disturbance
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
General physical health deterioration
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Hyperplasia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Hypothermia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Impaired healing
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Injection site extravasation
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Non-cardiac chest pain
|
0.56%
2/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Oedema peripheral
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Prosthetic cardiac valve stenosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Deep vein thrombosis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.9%
7/361 • Number of events 7 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Pyrexia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
12/355 • Number of events 13 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
4.7%
17/361 • Number of events 19 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.28%
1/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Femoral artery dissection
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Hypertension
|
2.3%
8/355 • Number of events 8 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Hypertensive crisis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Hypertensive emergency
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Hypertensive urgency
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Hypotension
|
1.4%
5/355 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Iliac artery dissection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Orthostatic hypotension
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Phlebitis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Peripheral artery occlusion
|
0.28%
1/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Peripheral artery stenosis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Peripheral ischaemia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Subclavian artery stenosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Subgaleal haematoma
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
General disorders
Unevaluable event
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Hepatobiliary disorders
Bile duct stone
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Immune system disorders
Amyloidosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Immune system disorders
Sarcoidosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Bacteraemia
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Breast abscess
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
COVID-19
|
1.4%
5/355 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
3.6%
13/361 • Number of events 14 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Cellulitis
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Device related infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Endocarditis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Enterococcal infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Enterococcal sepsis
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Erysipelas
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Gastroenteritis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Gastroenteritis viral
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Helicobacter infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Infective aneurysm
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Influenza
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Intervertebral discitis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Pneumonia
|
5.1%
18/355 • Number of events 20 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
4.4%
16/361 • Number of events 18 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Lung abscess
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Metapneumovirus infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Osteomyelitis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Prosthetic valve endocarditis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Pyelonephritis
|
0.28%
1/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Pyuria
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Respiratory tract infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Sepsis
|
2.0%
7/355 • Number of events 8 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Septic embolus
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Septic shock
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Urinary tract infection
|
2.3%
8/355 • Number of events 8 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
3.6%
13/361 • Number of events 13 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Urosepsis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Haemoglobin decreased
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Vascular access site cellulitis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Infections and infestations
Vascular access site infection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Aortic pseudoaneurysm
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Fall
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Injury
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.28%
1/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site dissection
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site occlusion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
1.4%
5/355 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular access site rupture
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Electrocardiogram P wave abnormal
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Electrocardiogram change
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Heart rate increased
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
SARS-CoV-2 test positive
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Transvalvular pressure gradient increased
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Investigations
Troponin increased
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Cachexia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.28%
1/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
7/355 • Number of events 7 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.56%
2/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Aphasia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cerebellar infarction
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cerebellar stroke
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.7%
6/361 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Embolic stroke
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cerebrovascular accident
|
3.9%
14/355 • Number of events 15 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
2.8%
10/361 • Number of events 10 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
50.0%
2/4 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Cognitive disorder
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Dementia
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Depressed level of consciousness
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Dizziness
|
0.85%
3/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Encephalopathy
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.7%
6/361 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Epilepsy
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Headache
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Ischaemic stroke
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Parkinson's disease
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Polyneuropathy
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Presyncope
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Product Issues
Lead dislodgement
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Sciatica
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Seizure
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Syncope
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
2.8%
10/361 • Number of events 10 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Transient ischaemic attack
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.7%
6/361 • Number of events 8 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Nervous system disorders
Vascular dementia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Product Issues
Device dislocation
|
0.85%
3/355 • Number of events 6 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Product Issues
Device failure
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Product Issues
Prosthetic cardiac valve failure
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Product Issues
Prosthetic cardiac valve malfunction
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
2.2%
8/361 • Number of events 8 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Psychiatric disorders
Delirium
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Psychiatric disorders
Major depression
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Psychiatric disorders
Mental disorder
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Psychiatric disorders
Mental status changes
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.1%
4/361 • Number of events 7 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
11/355 • Number of events 12 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
3.6%
13/361 • Number of events 16 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Haematuria
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Hydronephrosis
|
0.28%
1/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Renal impairment
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Renal infarct
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Urge incontinence
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
7/355 • Number of events 9 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
1.4%
5/361 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.85%
3/355 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
4/355 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pleurocutaneous fistula
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.55%
2/361 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
2/355 • Number of events 2 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.83%
3/361 • Number of events 3 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.28%
1/355 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Aortic dissection
|
1.4%
5/355 • Number of events 5 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/361 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
25.0%
1/4 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/355 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.28%
1/361 • Number of events 1 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
0.00%
0/4 • Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 2 Years post procedure for each subject.
All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place