Trial Outcomes & Findings for PERIGON Pivotal Trial (NCT NCT02088554)
NCT ID: NCT02088554
Last Updated: 2025-10-16
Results Overview
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1312 participants
Primary outcome timeframe
1 year post-implant
Results posted on
2025-10-16
Participant Flow
Participant milestones
| Measure |
Medtronic Model 400 Avalus Bioprosthetic Aortic Valve
The Medtronic Model 400 Avalus Bioprosthetic Aortic Valve is indicated for patients who require replacement of their native aortic valve.
|
|---|---|
|
Overall Study
STARTED
|
1312
|
|
Overall Study
Implanted
|
1132
|
|
Overall Study
1 Year Completion
|
1050
|
|
Overall Study
COMPLETED
|
268
|
|
Overall Study
NOT COMPLETED
|
1044
|
Reasons for withdrawal
| Measure |
Medtronic Model 400 Avalus Bioprosthetic Aortic Valve
The Medtronic Model 400 Avalus Bioprosthetic Aortic Valve is indicated for patients who require replacement of their native aortic valve.
|
|---|---|
|
Overall Study
Exited before procedure
|
130
|
|
Overall Study
Attempted but not implanted
|
31
|
|
Overall Study
Implant not attempted
|
19
|
|
Overall Study
Pending next visit
|
532
|
|
Overall Study
Death
|
170
|
|
Overall Study
Subject Withdrew + Physician Withdrew + Subject Not Implanted With Study Valve
|
96
|
|
Overall Study
Lost to Follow-up
|
23
|
|
Overall Study
Explanted
|
32
|
|
Overall Study
Any other reason not covered by previous categories
|
11
|
Baseline Characteristics
PERIGON Pivotal Trial
Baseline characteristics by cohort
| Measure |
Medtronic Model 400 Avalus Bioprosthetic Aortic Valve
n=1132 Participants
Participants implanted with the Medtronic Model 400 Avalus Bioprosthetic Aortic Valve, as indicated for patients who require replacement of their native aortic valve.
|
|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
278 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
854 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
638 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
475 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
636 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
476 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
268 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
475 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
389 participants
n=5 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA Class I
|
126 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA Class II
|
533 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA Class III
|
451 Participants
n=5 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA Class IV
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post-implantSafety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Explant
|
0.0 percentage of participants with event
|
0.9 percentage of participants with event
|
1.2 percentage of participants with event
|
0.6 percentage of participants with event
|
1.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.9 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
All death
|
9.5 percentage of participants with event
|
2.8 percentage of participants with event
|
2.2 percentage of participants with event
|
2.9 percentage of participants with event
|
4.0 percentage of participants with event
|
3.8 percentage of participants with event
|
3.0 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Valve- related death
|
0.0 percentage of participants with event
|
0.9 percentage of participants with event
|
0.2 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.3 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Thromboembolism
|
0.0 percentage of participants with event
|
2.8 percentage of participants with event
|
2.7 percentage of participants with event
|
2.9 percentage of participants with event
|
4.0 percentage of participants with event
|
3.8 percentage of participants with event
|
2.8 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Valve thrombosis
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
All hemorrhage
|
7.1 percentage of participants with event
|
3.8 percentage of participants with event
|
6.7 percentage of participants with event
|
4.3 percentage of participants with event
|
7.9 percentage of participants with event
|
0.0 percentage of participants with event
|
5.4 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Major hemorrhage
|
7.1 percentage of participants with event
|
0.5 percentage of participants with event
|
5.0 percentage of participants with event
|
3.4 percentage of participants with event
|
5.0 percentage of participants with event
|
0.0 percentage of participants with event
|
3.6 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
All paravalvular leak
|
0.0 percentage of participants with event
|
0.5 percentage of participants with event
|
0.5 percentage of participants with event
|
0.6 percentage of participants with event
|
1.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.5 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Major paravalvular leak
|
0.0 percentage of participants with event
|
0.5 percentage of participants with event
|
0.0 percentage of participants with event
|
0.3 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.2 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Endocarditis
|
0.0 percentage of participants with event
|
0.5 percentage of participants with event
|
1.5 percentage of participants with event
|
1.4 percentage of participants with event
|
1.0 percentage of participants with event
|
0.0 percentage of participants with event
|
1.1 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Hemolysis
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Non-structural valve dysfunction
|
0.0 percentage of participants with event
|
0.5 percentage of participants with event
|
0.5 percentage of participants with event
|
0.6 percentage of participants with event
|
1.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.5 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Structural valve deterioration
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Severe hemodynamic dysfunction - indeterminate or evolving cause
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.0 percentage of participants with event
|
|
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Reintervention
|
0.0 percentage of participants with event
|
0.9 percentage of participants with event
|
1.2 percentage of participants with event
|
0.6 percentage of participants with event
|
1.0 percentage of participants with event
|
0.0 percentage of participants with event
|
0.9 percentage of participants with event
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: Difference in the overall number of participants analyzed and of those analyzed at each timepoint is due to classification not assessed, classification was unable to be assessed, or the participant exited the trial before that timepoint. For 29mm participants, difference in total number of participants analyzed was also due to participants who have not yet reached specified timepoint.
At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · Improved 3 Classes
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
9 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · Worsened 1 Class
|
0 Participants
|
15 Participants
|
16 Participants
|
18 Participants
|
10 Participants
|
3 Participants
|
62 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · No Change
|
12 Participants
|
61 Participants
|
118 Participants
|
116 Participants
|
23 Participants
|
7 Participants
|
337 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · Worsened 2 Classes
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · Improved 2 Classes
|
5 Participants
|
14 Participants
|
30 Participants
|
27 Participants
|
9 Participants
|
1 Participants
|
86 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · Improved 1 Class
|
21 Participants
|
83 Participants
|
131 Participants
|
108 Participants
|
26 Participants
|
12 Participants
|
382 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
Discharge up to 30 days · Worsened 3 Classes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · Improved 3 Classes
|
0 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
12 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · Improved 1 Class
|
20 Participants
|
97 Participants
|
187 Participants
|
164 Participants
|
43 Participants
|
13 Participants
|
525 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · No Change
|
5 Participants
|
47 Participants
|
76 Participants
|
79 Participants
|
25 Participants
|
4 Participants
|
236 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · Worsened 2 Classes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · Worsened 1 Class
|
0 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
18 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · Improved 2 Classes
|
15 Participants
|
51 Participants
|
103 Participants
|
82 Participants
|
27 Participants
|
4 Participants
|
282 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
3-6 Months · Worsened 3 Classes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · No Change
|
8 Participants
|
47 Participants
|
76 Participants
|
70 Participants
|
26 Participants
|
3 Participants
|
230 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · Improved 1 Class
|
16 Participants
|
83 Participants
|
176 Participants
|
161 Participants
|
40 Participants
|
10 Participants
|
486 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · Improved 3 Classes
|
0 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
13 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · Improved 2 Classes
|
13 Participants
|
60 Participants
|
105 Participants
|
79 Participants
|
27 Participants
|
4 Participants
|
289 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · Worsened 1 Class
|
0 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
17 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · Worsened 2 Classes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
1 Year · Worsened 3 Classes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
Discharge (up to 30 days)
|
1.23 cm^2
Standard Deviation 0.24
|
1.35 cm^2
Standard Deviation 0.30
|
1.59 cm^2
Standard Deviation 0.34
|
1.68 cm^2
Standard Deviation 0.37
|
1.88 cm^2
Standard Deviation 0.42
|
2.29 cm^2
Standard Deviation 0.68
|
1.60 cm^2
Standard Deviation 0.40
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
3-6 Months
|
1.22 cm^2
Standard Deviation 0.27
|
1.30 cm^2
Standard Deviation 0.26
|
1.54 cm^2
Standard Deviation 0.30
|
1.66 cm^2
Standard Deviation 0.32
|
1.89 cm^2
Standard Deviation 0.42
|
2.51 cm^2
Standard Deviation 0.71
|
1.57 cm^2
Standard Deviation 0.39
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
1 Year
|
1.09 cm^2
Standard Deviation 0.23
|
1.26 cm^2
Standard Deviation 0.25
|
1.48 cm^2
Standard Deviation 0.33
|
1.60 cm^2
Standard Deviation 0.34
|
1.76 cm^2
Standard Deviation 0.35
|
2.42 cm^2
Standard Deviation 0.59
|
1.50 cm^2
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
1 Year
|
0.63 cm^2/m^2
Standard Deviation 0.14
|
0.70 cm^2/m^2
Standard Deviation 0.15
|
0.76 cm^2/m^2
Standard Deviation 0.18
|
0.78 cm^2/m^2
Standard Deviation 0.17
|
0.82 cm^2/m^2
Standard Deviation 0.17
|
1.14 cm^2/m^2
Standard Deviation 0.28
|
0.76 cm^2/m^2
Standard Deviation 0.18
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
Discharge (up to 30 days)
|
0.71 cm^2/m^2
Standard Deviation 0.16
|
0.74 cm^2/m^2
Standard Deviation 0.18
|
0.81 cm^2/m^2
Standard Deviation 0.20
|
0.81 cm^2/m^2
Standard Deviation 0.19
|
0.89 cm^2/m^2
Standard Deviation 0.23
|
1.07 cm^2/m^2
Standard Deviation 0.3
|
0.81 cm^2/m^2
Standard Deviation 0.20
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
3-6 Months
|
0.71 cm^2/m^2
Standard Deviation 0.17
|
0.72 cm^2/m^2
Standard Deviation 0.16
|
0.79 cm^2/m^2
Standard Deviation 0.17
|
0.81 cm^2/m^2
Standard Deviation 0.17
|
0.90 cm^2/m^2
Standard Deviation 0.22
|
1.16 cm^2/m^2
Standard Deviation 0.31
|
0.80 cm^2/m^2
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
Discharge (up to 30 days)
|
32.2 mmHg
Standard Deviation 9.7
|
28.0 mmHg
Standard Deviation 9.2
|
23.6 mmHg
Standard Deviation 8.0
|
22.4 mmHg
Standard Deviation 6.8
|
19.6 mmHg
Standard Deviation 6.8
|
16.2 mmHg
Standard Deviation 6.3
|
23.9 mmHg
Standard Deviation 8.4
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
3-6 Months
|
27.2 mmHg
Standard Deviation 6.7
|
26.3 mmHg
Standard Deviation 8.6
|
21.6 mmHg
Standard Deviation 6.8
|
21.1 mmHg
Standard Deviation 7.2
|
17.7 mmHg
Standard Deviation 5.9
|
14.7 mmHg
Standard Deviation 6.3
|
22.1 mmHg
Standard Deviation 7.7
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
1 Year
|
30.4 mmHg
Standard Deviation 8.2
|
27.8 mmHg
Standard Deviation 9.4
|
23.1 mmHg
Standard Deviation 7.5
|
22.0 mmHg
Standard Deviation 7.3
|
19.0 mmHg
Standard Deviation 6.7
|
18.1 mmHg
Standard Deviation 6.5
|
23.5 mmHg
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
Discharge (up to 30 days)
|
18.2 mmHg
Standard Deviation 6.1
|
15.2 mmHg
Standard Deviation 4.9
|
12.9 mmHg
Standard Deviation 4.5
|
12.4 mmHg
Standard Deviation 3.9
|
10.7 mmHg
Standard Deviation 3.8
|
8.8 mmHg
Standard Deviation 3.5
|
13.1 mmHg
Standard Deviation 4.7
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
3-6 Months
|
15.4 mmHg
Standard Deviation 4.4
|
14.2 mmHg
Standard Deviation 4.6
|
11.7 mmHg
Standard Deviation 3.7
|
11.3 mmHg
Standard Deviation 3.7
|
9.6 mmHg
Standard Deviation 3.3
|
7.9 mmHg
Standard Deviation 3.6
|
11.9 mmHg
Standard Deviation 4.1
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
1 Year
|
17.1 mmHg
Standard Deviation 5.0
|
15.1 mmHg
Standard Deviation 5.3
|
12.3 mmHg
Standard Deviation 4.0
|
11.9 mmHg
Standard Deviation 4.0
|
10.1 mmHg
Standard Deviation 3.7
|
10.2 mmHg
Standard Deviation 3.5
|
12.7 mmHg
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
Discharge (up to 30 days)
|
0.5 L/min
Standard Deviation 0.1
|
0.5 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
3-6 Months
|
0.5 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
1 Year
|
0.5 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.3 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
0.4 L/min
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
Discharge (up to 30 days)
|
5.0 L/min
Standard Deviation 1.0
|
4.9 L/min
Standard Deviation 1.2
|
5.1 L/min
Standard Deviation 1.3
|
5.2 L/min
Standard Deviation 1.2
|
5.3 L/min
Standard Deviation 1.4
|
5.2 L/min
Standard Deviation 1.2
|
5.1 L/min
Standard Deviation 1.3
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
3-6 Months
|
4.6 L/min
Standard Deviation 1.1
|
4.5 L/min
Standard Deviation 0.9
|
4.8 L/min
Standard Deviation 1.0
|
4.9 L/min
Standard Deviation 1.1
|
4.9 L/min
Standard Deviation 1.2
|
5.8 L/min
Standard Deviation 1.7
|
4.8 L/min
Standard Deviation 1.1
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
1 Year
|
4.3 L/min
Standard Deviation 1.0
|
4.5 L/min
Standard Deviation 1.1
|
4.7 L/min
Standard Deviation 1.1
|
4.9 L/min
Standard Deviation 1.2
|
4.8 L/min
Standard Deviation 1.0
|
6.4 L/min
Standard Deviation 2.0
|
4.7 L/min
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implantPopulation: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Outcome measures
| Measure |
Medtronic Avalus Valve 19mm
n=42 Participants
Safety evaluation for participants implanted with the 19mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 21mm
n=211 Participants
Safety evaluation for participants implanted with the 21mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 23mm
n=401 Participants
Safety evaluation for participants implanted with the 23mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 25mm
n=350 Participants
Safety evaluation for participants implanted with the 25mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 27mm
n=101 Participants
Safety evaluation for participants implanted with the 27mm Medtronic Avalus Valve
|
Medtronic Avalus Valve 29mm
n=26 Participants
Safety evaluation for participants implanted with the 29mm Medtronic Avalus Valve
|
Medtronic Avalus Valve (17mm - 29mm)
n=1132 Participants
Safety evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy.
|
|---|---|---|---|---|---|---|---|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
Discharge (up to 30 days)
|
2.9 L/min/m^2
Standard Deviation 0.7
|
2.7 L/min/m^2
Standard Deviation 0.7
|
2.6 L/min/m^2
Standard Deviation 0.7
|
2.5 L/min/m^2
Standard Deviation 0.6
|
2.5 L/min/m^2
Standard Deviation 0.7
|
2.4 L/min/m^2
Standard Deviation 0.6
|
2.6 L/min/m^2
Standard Deviation 0.7
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
3-6 Months
|
2.7 L/min/m^2
Standard Deviation 0.7
|
2.5 L/min/m^2
Standard Deviation 0.5
|
2.4 L/min/m^2
Standard Deviation 0.5
|
2.4 L/min/m^2
Standard Deviation 0.5
|
2.3 L/min/m^2
Standard Deviation 0.6
|
2.7 L/min/m^2
Standard Deviation 0.7
|
2.4 L/min/m^2
Standard Deviation 0.5
|
|
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
1 Year
|
2.5 L/min/m^2
Standard Deviation 0.5
|
2.5 L/min/m^2
Standard Deviation 0.6
|
2.4 L/min/m^2
Standard Deviation 0.5
|
2.4 L/min/m^2
Standard Deviation 0.6
|
2.2 L/min/m^2
Standard Deviation 0.4
|
3.0 L/min/m^2
Standard Deviation 0.8
|
2.4 L/min/m^2
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantSafety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantAt each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantEvaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantPerformance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantCardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Annually, at years 2, 3, 4, and 5 post-implantEvaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year post-implantSafety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months and 1 year post-implantParticipants evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, 1 year post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, and 1 year post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, and 1 year post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, and 1 year post-implantEvaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, and 1 year post-implantPerformance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, and 1 year post-implantCardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-6 months, and 1 year post-implantEvaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6-12 post-implantLong-term follow-up clinically acceptable hemodynamic performance defined as freedom from surgical explant and/or percutaneous valve-in-valve reintervention due to structural valve deterioration
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantFor time-to-event outcomes, Kaplan-Meier (actuarial) analysis of the event-free rate performed annually through twelve years.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantEvaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantEvaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantPerformance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantCardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Annually, years 6 though 12 post-implantEvaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Outcome measures
Outcome data not reported
Adverse Events
Medtronic Avalus Valve (All valve sizes)
Serious events: 638 serious events
Other events: 1105 other events
Deaths: 170 deaths
Serious adverse events
| Measure |
Medtronic Avalus Valve (All valve sizes)
n=1132 participants at risk
All participants implanted with the with Medtronic Avalus Valve (sized 17mm - 29mm) from procedure through 1 year.
|
|---|---|
|
Gastrointestinal Disorders
Duodenal And Small Intestinal Stenosis And Obstruction
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Duodenal Ulcers And Perforation
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastric And Oesophageal Haemorrhages
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastritis (Excl Infective)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastrointestinal Atonic And Hypomotility Disorders Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastrointestinal Signs And Symptoms Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastrointestinal Stenosis And Obstruction Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastrointestinal Ulcers And Perforation, Site Unspecified
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastrointestinal Vascular Occlusion And Infarction
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Inguinal Hernias
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Intestinal Haemorrhages
|
0.62%
7/1132 • Number of events 7 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Non-Mechanical Ileus
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Non-Site Specific Gastrointestinal Haemorrhages
|
0.97%
11/1132 • Number of events 11 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Peritoneal And Retroperitoneal Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Pericardial Disorders Nec
|
4.3%
49/1132 • Number of events 54 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Rate And Rhythm Disorders Nec
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Supraventricular Arrhythmias
|
12.9%
146/1132 • Number of events 167 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Tricuspid Valvular Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Diverticula
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Ventricular Arrhythmias And Cardiac Arrest
|
2.7%
31/1132 • Number of events 31 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Congenital, Familial And Genetic Disorders
Cardiac Septal Defects Congenital
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Ear And Labyrinth Disorders
Inner Ear Signs And Symptoms
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Endocrine Disorders
Thyroid Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Eye Disorders
Optic Nerve Bleeding And Vascular Disorders
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Eye Disorders
Retinal Structural Change, Deposit And Degeneration
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Eye Disorders
Visual Impairment And Blindness (Excl Colour Blindness)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Acute And Chronic Pancreatitis
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Anal And Rectal Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Anal And Rectal Ulcers And Perforation
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Benign Neoplasms Gastrointestinal (Excl Oral Cavity)
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Colitis (Excl Infective)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Diaphragmatic Hernias
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Diarrhoea (Excl Infective)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Anaemias Haemolytic Immune
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Anaemias Nec
|
8.7%
98/1132 • Number of events 106 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Bleeding Tendencies
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Coagulopathies
|
0.88%
10/1132 • Number of events 10 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Haemolyses Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Leukocytoses Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Leukopenias Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Spleen Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Thrombocytopenias
|
1.6%
18/1132 • Number of events 18 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Cardiac Conduction Disorders
|
4.3%
49/1132 • Number of events 55 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Cardiac Disorders Nec
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Cardiomyopathies
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Coronary Artery Disorders Nec
|
1.1%
12/1132 • Number of events 12 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Heart Failures Nec
|
3.8%
43/1132 • Number of events 46 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Ischaemic Coronary Artery Disorders
|
1.1%
13/1132 • Number of events 13 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Left Ventricular Failures
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Mitral Valvular Disorders
|
0.53%
6/1132 • Number of events 6 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Myocardial Disorders Nec
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Noninfectious Pericarditis
|
0.53%
6/1132 • Number of events 6 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Cardiac Complications Associated With Device
|
0.71%
8/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Complications Associated With Device Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Death And Sudden Death
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Febrile Disorders
|
0.53%
6/1132 • Number of events 6 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
General Signs And Symptoms Nec
|
0.80%
9/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Healing Abnormal Nec
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Hernias Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Oedema Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Pain And Discomfort Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Vascular Complications Associated With Device
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Hepatobiliary Disorders
Cholecystitis And Cholelithiasis
|
0.62%
7/1132 • Number of events 7 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Hepatobiliary Disorders
Cholestasis And Jaundice
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Hepatobiliary Disorders
Hepatic And Hepatobiliary Disorders Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Hepatobiliary Disorders
Hepatic Failure And Associated Disorders
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Hepatobiliary Disorders
Obstructive Bile Duct Disorders (Excl Neoplasms)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Hepatobiliary Disorders
Structural And Other Bile Duct Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Immune System Disorders
Allergies To Foods, Food Additives, Drugs And Other Chemicals
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Immune System Disorders
Anaphylactic And Anaphylactoid Responses
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Abdominal And Gastrointestinal Infections
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Bacterial Infections Nec
|
0.80%
9/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Bone And Joint Infections
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Cardiac Infections
|
1.3%
15/1132 • Number of events 16 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Clostridia Infections
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Coronavirus Infections
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Fungal Infections Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Herpes Viral Infections
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Infections Nec
|
1.4%
16/1132 • Number of events 19 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Lower Respiratory Tract And Lung Infections
|
3.2%
36/1132 • Number of events 39 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
|
2.7%
31/1132 • Number of events 33 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Streptococcal Infections
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Upper Respiratory Tract Infections
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Urinary Tract Infections
|
0.80%
9/1132 • Number of events 11 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Vascular Infections
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Viral Infections Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Abdominal And Gastrointestinal Injuries Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Anaesthetic And Allied Procedural Complications
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Bone And Joint Injuries Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Cardiac And Vascular Procedural Complications
|
1.3%
15/1132 • Number of events 15 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Cardiovascular Injuries
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Cerebral Injuries Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Eye Injuries Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Gastrointestinal And Hepatobiliary Procedural Complications
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Limb Fractures And Dislocations
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Medication Errors, Product Use Errors And Issues Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Nerve Injuries Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Non-Site Specific Injuries Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Non-Site Specific Procedural Complications
|
4.9%
55/1132 • Number of events 57 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Respiratory Tract And Thoracic Cavity Procedural Complications
|
0.71%
8/1132 • Number of events 10 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Site Specific Injuries Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Skin Injuries Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Spinal Fractures And Dislocations
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Thoracic Cage Fractures And Dislocations
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Urinary Tract Procedural Complications
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Carbohydrate Tolerance Analyses (Incl Diabetes)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Cardiac Function Diagnostic Procedures
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Coagulation And Bleeding Analyses
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Mineral And Electrolyte Analyses
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Protein Analyses Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Red Blood Cell Analyses
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Renal Function Analyses
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Respiratory Tract And Thoracic Histopathology Procedures
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Skeletal And Cardiac Muscle Analyses
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Vascular Tests Nec (Incl Blood Pressure)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
White Blood Cell Analyses
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Disorders Of Purine Metabolism
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Hyperglycaemic Conditions Nec
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Metabolic Acidoses (Excl Diabetic Acidoses)
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Sodium Imbalance
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Total Fluid Volume Decreased
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Total Fluid Volume Increased
|
0.35%
4/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Cartilage Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Joint Related Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Muscle Weakness Conditions
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Musculoskeletal And Connective Tissue Conditions Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Musculoskeletal And Connective Tissue Pain And Discomfort
|
1.1%
12/1132 • Number of events 12 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Myopathies
|
0.09%
1/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Osteoarthropathies
|
0.62%
7/1132 • Number of events 7 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Spine And Neck Deformities
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Bladder Neoplasms Malignant
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Breast And Nipple Neoplasms Malignant
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Central Nervous System Neoplasms Malignant Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Endocrine Neoplasms Malignant And Unspecified Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Female Reproductive Neoplasms Unspecified Malignancy
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Gallbladder Neoplasms Malignant
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Laryngeal Neoplasms Malignant
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Leukaemias Acute Myeloid
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Lower Gastrointestinal Neoplasms Benign
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Myelodysplastic Syndromes
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Neoplasms Malignant Site Unspecified Nec
|
1.9%
21/1132 • Number of events 21 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Prostatic Neoplasms Malignant
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Renal Neoplasms Benign
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Renal Neoplasms Malignant
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Urinary Tract Neoplasms Unspecified Malignancy Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Acute Polyneuropathies
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Central Nervous System Haemorrhages And Cerebrovascular Accidents
|
3.3%
37/1132 • Number of events 38 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Central Nervous System Vascular Disorders Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Coordination And Balance Disturbances
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Dementia (Excl Alzheimer's Type)
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Disturbances In Consciousness Nec
|
0.88%
10/1132 • Number of events 11 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Encephalopathies Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Encephalopathies Toxic And Metabolic
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Headaches Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Hydrocephalic Conditions
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Increased Intracranial Pressure Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Lumbar Spinal Cord And Nerve Root Disorders
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Neurological Signs And Symptoms Nec
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Neuromuscular Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Parkinson's Disease And Parkinsonism
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Peripheral Neuropathies Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Seizures And Seizure Disorders Nec
|
0.80%
9/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Spinal Cord And Nerve Root Disorders Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Structural Brain Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Transient Cerebrovascular Events
|
1.2%
14/1132 • Number of events 14 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Tremor (Excl Congenital)
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Product Issues
Device Incompatibility Issues
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Product Issues
Device Issues Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Product Issues
Device Malfunction Events Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Anxiety Symptoms
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Confusion And Disorientation
|
1.1%
12/1132 • Number of events 12 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Delusional Symptoms
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Depressive Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Mental Disorders Nec
|
0.80%
9/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Substance Related And Addictive Disorders
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Bladder And Urethral Symptoms
|
0.53%
6/1132 • Number of events 6 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Nephritis Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Renal Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Renal Failure And Impairment
|
3.4%
38/1132 • Number of events 45 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Renal Lithiasis
|
0.27%
3/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Renal Obstructive Disorders
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Urinary Abnormalities
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Reproductive System And Breast Disorders
Testicular And Epididymal Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Breathing Abnormalities
|
0.80%
9/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Bronchospasm And Obstruction
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Conditions Associated With Abnormal Gas Exchange
|
0.44%
5/1132 • Number of events 5 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Coughing And Associated Symptoms
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Lower Respiratory Tract Inflammatory And Immunologic Conditions
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Lower Respiratory Tract Signs And Symptoms
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Mediastinal Disorders
|
0.88%
10/1132 • Number of events 10 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Nasal Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Parenchymal Lung Disorders Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Pneumothorax And Pleural Effusions Nec
|
9.8%
111/1132 • Number of events 119 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Pulmonary Oedemas
|
0.97%
11/1132 • Number of events 11 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Pulmonary Thrombotic And Embolic Conditions
|
0.53%
6/1132 • Number of events 6 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Respiratory Failures (Excl Neonatal)
|
3.5%
40/1132 • Number of events 43 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Respiratory Tract Disorders Nec
|
0.27%
3/1132 • Number of events 3 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Skin And Subcutaneous Tissue Disorders
Dermal And Epidermal Conditions Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Skin And Subcutaneous Tissue Disorders
Rashes, Eruptions And Exanthems Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Skin And Subcutaneous Tissue Disorders
Skin Injuries And Mechanical Dermatoses
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Skin And Subcutaneous Tissue Disorders
Skin Preneoplastic Conditions Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Surgical And Medical Procedures
Cardiac Device Therapeutic Procedures
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Surgical And Medical Procedures
Cardiac Therapeutic Procedures Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Surgical And Medical Procedures
Gastrointestinal Therapeutic Procedures Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Surgical And Medical Procedures
Therapeutic Procedures Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Aortic Aneurysms And Dissections
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Aortic Necrosis And Vascular Insufficiency
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Circulatory Collapse And Shock
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Haemorrhages Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Lymphangiopathies
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Non-Site Specific Embolism And Thrombosis
|
0.35%
4/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Non-Site Specific Necrosis And Vascular Insufficiency Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Non-Site Specific Vascular Disorders Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Peripheral Embolism And Thrombosis
|
0.27%
3/1132 • Number of events 4 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Peripheral Vascular Disorders Nec
|
0.18%
2/1132 • Number of events 2 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Site Specific Necrosis And Vascular Insufficiency Nec
|
0.09%
1/1132 • Number of events 1 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Site Specific Vascular Disorders Nec
|
0.53%
6/1132 • Number of events 6 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Vascular Hypertensive Disorders Nec
|
0.80%
9/1132 • Number of events 9 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Vascular Hypotensive Disorders
|
2.3%
26/1132 • Number of events 26 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
Other adverse events
| Measure |
Medtronic Avalus Valve (All valve sizes)
n=1132 participants at risk
All participants implanted with the with Medtronic Avalus Valve (sized 17mm - 29mm) from procedure through 1 year.
|
|---|---|
|
Blood And Lymphatic System Disorders
Anaemias Nec
|
37.1%
420/1132 • Number of events 446 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Leukocytoses Nec
|
7.7%
87/1132 • Number of events 89 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Blood And Lymphatic System Disorders
Thrombocytopenias
|
22.5%
255/1132 • Number of events 267 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Cardiac Conduction Disorders
|
35.0%
396/1132 • Number of events 532 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Heart Failures Nec
|
6.1%
69/1132 • Number of events 85 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Pericardial Disorders Nec
|
14.8%
167/1132 • Number of events 184 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Supraventricular Arrhythmias
|
59.5%
674/1132 • Number of events 930 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Tricuspid Valvular Disorders
|
6.8%
77/1132 • Number of events 79 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Cardiac Disorders
Ventricular Arrhythmias And Cardiac Arrest
|
11.3%
128/1132 • Number of events 139 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Gastrointestinal Atonic And Hypomotility Disorders Nec
|
5.7%
65/1132 • Number of events 68 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Gastrointestinal Disorders
Nausea And Vomiting Symptoms
|
8.5%
96/1132 • Number of events 104 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
General Disorders And Administration Site Conditions
Oedema Nec
|
16.2%
183/1132 • Number of events 189 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Lower Respiratory Tract And Lung Infections
|
6.4%
73/1132 • Number of events 85 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Infections And Infestations
Urinary Tract Infections
|
6.2%
70/1132 • Number of events 76 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Gastrointestinal And Hepatobiliary Procedural Complications
|
5.1%
58/1132 • Number of events 61 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Injury, Poisoning And Procedural Complications
Non-Site Specific Procedural Complications
|
24.4%
276/1132 • Number of events 328 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Investigations
Physical Examination Procedures And Organ System Status
|
6.4%
73/1132 • Number of events 73 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Electrolyte Imbalance Nec
|
6.2%
70/1132 • Number of events 75 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Hyperglycaemic Conditions Nec
|
19.4%
220/1132 • Number of events 231 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Potassium Imbalance
|
5.3%
60/1132 • Number of events 67 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Metabolism And Nutrition Disorders
Total Fluid Volume Increased
|
5.7%
65/1132 • Number of events 66 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Musculoskeletal And Connective Tissue Disorders
Musculoskeletal And Connective Tissue Pain And Discomfort
|
11.2%
127/1132 • Number of events 138 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Nervous System Disorders
Neurological Signs And Symptoms Nec
|
7.3%
83/1132 • Number of events 86 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Psychiatric Disorders
Confusion And Disorientation
|
10.6%
120/1132 • Number of events 126 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Bladder And Urethral Symptoms
|
8.9%
101/1132 • Number of events 110 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Renal And Urinary Disorders
Renal Failure And Impairment
|
14.5%
164/1132 • Number of events 186 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Breathing Abnormalities
|
6.8%
77/1132 • Number of events 80 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Parenchymal Lung Disorders Nec
|
11.2%
127/1132 • Number of events 133 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Pneumothorax And Pleural Effusions Nec
|
34.2%
387/1132 • Number of events 442 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Pulmonary Oedemas
|
10.8%
122/1132 • Number of events 125 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Respiratory, Thoracic And Mediastinal Disorders
Respiratory Failures (Excl Neonatal)
|
11.4%
129/1132 • Number of events 138 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Vascular Hypertensive Disorders Nec
|
14.0%
158/1132 • Number of events 184 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
|
Vascular Disorders
Vascular Hypotensive Disorders
|
19.9%
225/1132 • Number of events 252 • Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
|
Additional Information
Jessica Halverson, Director of Clinical Research
Medtronic
Phone: (800) 633-8766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) \& won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) \& its rights in patentable or copyrightable materials, \& check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.
- Publication restrictions are in place
Restriction type: OTHER