Trial Outcomes & Findings for ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement (NCT NCT03735667)
NCT ID: NCT03735667
Last Updated: 2025-12-10
Results Overview
Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1948 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay through 1 year.
Results posted on
2025-12-10
Participant Flow
Main Randomized Cohort: 1500 subjects randomized from 10Jun2019 to 19Apr2023. Roll-in Cohort: 148 subjects enrolled from 10Jul2019 to 27Feb2023.
The non-randomized Roll-in phase with only the test device was for centers with no previous experience implanting ACURATE. Each applicable site performed at least two Roll-in cases before starting enrollment in the Main Randomized Cohort. Only data for the Main Randomized Cohort and Roll-in Cohort are being reported at this time as data for the 4D-CT Substudy and other 3 cohorts (Continued Access Study, Extended Durability, and Prime XL Nested Registry) are not available.
Participant milestones
| Measure |
ACURATE neo2 Valve - Main Randomized
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
ACURATE neo 2 Valve - Single-arm Roll-in
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
|---|---|---|---|
|
1 Year PE Main Randomized and Roll-in
STARTED
|
752
|
748
|
148
|
|
1 Year PE Main Randomized and Roll-in
Eligible 1-Year
|
716
|
720
|
141
|
|
1 Year PE Main Randomized and Roll-in
COMPLETED
|
649
|
658
|
130
|
|
1 Year PE Main Randomized and Roll-in
NOT COMPLETED
|
103
|
90
|
18
|
|
4D-CT Substudy (subset of Main RCT)
STARTED
|
160
|
158
|
0
|
|
4D-CT Substudy (subset of Main RCT)
Eligible 1 Year 4D-CT
|
153
|
154
|
0
|
|
4D-CT Substudy (subset of Main RCT)
COMPLETED
|
143
|
144
|
0
|
|
4D-CT Substudy (subset of Main RCT)
NOT COMPLETED
|
17
|
14
|
0
|
Reasons for withdrawal
| Measure |
ACURATE neo2 Valve - Main Randomized
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
ACURATE neo 2 Valve - Single-arm Roll-in
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
|---|---|---|---|
|
1 Year PE Main Randomized and Roll-in
Death
|
40
|
31
|
7
|
|
1 Year PE Main Randomized and Roll-in
Lost to Follow-up
|
3
|
2
|
0
|
|
1 Year PE Main Randomized and Roll-in
Physician Decision
|
4
|
2
|
0
|
|
1 Year PE Main Randomized and Roll-in
Withdrawal by Subject
|
27
|
24
|
2
|
|
1 Year PE Main Randomized and Roll-in
1-Year Visit Not Done
|
28
|
29
|
9
|
|
1 Year PE Main Randomized and Roll-in
Other
|
1
|
2
|
0
|
|
4D-CT Substudy (subset of Main RCT)
Death
|
8
|
5
|
0
|
|
4D-CT Substudy (subset of Main RCT)
Withdrawal by Subject
|
4
|
4
|
0
|
|
4D-CT Substudy (subset of Main RCT)
Lost to Follow-up
|
1
|
0
|
0
|
|
4D-CT Substudy (subset of Main RCT)
Physician Decision
|
1
|
1
|
0
|
|
4D-CT Substudy (subset of Main RCT)
Other
|
0
|
1
|
0
|
|
4D-CT Substudy (subset of Main RCT)
1-Year Visit Not Done
|
3
|
3
|
0
|
Baseline Characteristics
Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
Baseline characteristics by cohort
| Measure |
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR,Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
Total
n=1648 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
78.0 Years
STANDARD_DEVIATION 6.9 • n=752 Participants
|
79.0 Years
STANDARD_DEVIATION 6.5 • n=748 Participants
|
78.8 Years
STANDARD_DEVIATION 7.1 • n=148 Participants
|
78.5 Years
STANDARD_DEVIATION 6.8 • n=1648 Participants
|
|
Sex/Gender, Customized
Male
|
357 Participants
n=752 Participants
|
364 Participants
n=748 Participants
|
64 Participants
n=148 Participants
|
785 Participants
n=1648 Participants
|
|
Sex/Gender, Customized
Female
|
395 Participants
n=752 Participants
|
383 Participants
n=748 Participants
|
84 Participants
n=148 Participants
|
862 Participants
n=1648 Participants
|
|
Sex/Gender, Customized
Intersex
|
0 Participants
n=752 Participants
|
0 Participants
n=748 Participants
|
0 Participants
n=148 Participants
|
0 Participants
n=1648 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=752 Participants
|
1 Participants
n=748 Participants
|
0 Participants
n=148 Participants
|
1 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=752 Participants
|
0 Participants
n=748 Participants
|
1 Participants
n=148 Participants
|
4 Participants
n=1648 Participants
|
|
Medical History
History of congestive heart failure
|
31.6 Percentage of participants
n=752 Participants
|
35.0 Percentage of participants
n=748 Participants
|
47.3 Percentage of participants
n=148 Participants
|
34.6 Percentage of participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=752 Participants
|
13 Participants
n=748 Participants
|
1 Participants
n=148 Participants
|
20 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Asian - Chinese
|
0 Participants
n=752 Participants
|
3 Participants
n=748 Participants
|
0 Participants
n=148 Participants
|
3 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese
|
1 Participants
n=752 Participants
|
0 Participants
n=748 Participants
|
0 Participants
n=148 Participants
|
1 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Asian - Korean
|
2 Participants
n=752 Participants
|
1 Participants
n=748 Participants
|
1 Participants
n=148 Participants
|
4 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
3 Participants
n=752 Participants
|
9 Participants
n=748 Participants
|
0 Participants
n=148 Participants
|
12 Participants
n=1648 Participants
|
|
Medical History
History of atrial fibrillation/atrial flutter
|
24.1 Percentage of participants
n=752 Participants
|
23.4 Percentage of participants
n=748 Participants
|
34.5 Percentage of participants
n=148 Participants
|
24.7 Percentage of participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
29 Participants
n=752 Participants
|
23 Participants
n=748 Participants
|
3 Participants
n=148 Participants
|
55 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
675 Participants
n=752 Participants
|
659 Participants
n=748 Participants
|
137 Participants
n=148 Participants
|
1471 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=752 Participants
|
1 Participants
n=748 Participants
|
0 Participants
n=148 Participants
|
1 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=752 Participants
|
11 Participants
n=748 Participants
|
2 Participants
n=148 Participants
|
26 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
5 Participants
n=752 Participants
|
14 Participants
n=748 Participants
|
1 Participants
n=148 Participants
|
20 Participants
n=1648 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
24 Participants
n=752 Participants
|
27 Participants
n=748 Participants
|
3 Participants
n=148 Participants
|
54 Participants
n=1648 Participants
|
|
Region of Enrollment
Canada
|
59 participants
n=752 Participants
|
61 participants
n=748 Participants
|
0 participants
n=148 Participants
|
120 participants
n=1648 Participants
|
|
Region of Enrollment
United States
|
693 participants
n=752 Participants
|
687 participants
n=748 Participants
|
148 participants
n=148 Participants
|
1528 participants
n=1648 Participants
|
|
Body Mass Index (BMI)
|
30.6 kg/m2
STANDARD_DEVIATION 6.5 • n=752 Participants
|
29.8 kg/m2
STANDARD_DEVIATION 6.1 • n=748 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 7.8 • n=148 Participants
|
30.3 kg/m2
STANDARD_DEVIATION 6.5 • n=1648 Participants
|
|
Aortic Annulus Area
|
435.2 mm2
STANDARD_DEVIATION 58.7 • n=752 Participants
|
437.3 mm2
STANDARD_DEVIATION 54.7 • n=748 Participants
|
439.6 mm2
STANDARD_DEVIATION 56.6 • n=148 Participants
|
436.5 mm2
STANDARD_DEVIATION 56.7 • n=1648 Participants
|
|
Aortic Annulus Perimeter
|
74.8 mm
STANDARD_DEVIATION 5.0 • n=752 Participants
|
75.1 mm
STANDARD_DEVIATION 4.6 • n=748 Participants
|
75.2 mm
STANDARD_DEVIATION 4.9 • n=148 Participants
|
75.0 mm
STANDARD_DEVIATION 4.8 • n=1648 Participants
|
|
Medical History
History of hypertension
|
89.4 Percentage of participants
n=752 Participants
|
88.0 Percentage of participants
n=748 Participants
|
91.2 Percentage of participants
n=148 Participants
|
88.9 Percentage of participants
n=1648 Participants
|
|
Medical History
History of coronary artery disease
|
52.1 Percentage of participants
n=752 Participants
|
52.9 Percentage of participants
n=748 Participants
|
58.1 Percentage of participants
n=148 Participants
|
53.0 Percentage of participants
n=1648 Participants
|
|
Medical History
History of myocardial infarction
|
8.6 Percentage of participants
n=752 Participants
|
7.8 Percentage of participants
n=748 Participants
|
10.8 Percentage of participants
n=148 Participants
|
8.4 Percentage of participants
n=1648 Participants
|
|
Medical History
Prior pacemaker implant
|
6.4 Percentage of participants
n=752 Participants
|
7.0 Percentage of participants
n=748 Participants
|
11.5 Percentage of participants
n=148 Participants
|
7.1 Percentage of participants
n=1648 Participants
|
|
Medical History
History of cerebrovascular accident (TIA & stroke)
|
13.0 Percentage of participants
n=752 Participants
|
11.5 Percentage of participants
n=748 Participants
|
12.2 Percentage of participants
n=148 Participants
|
12.3 Percentage of participants
n=1648 Participants
|
|
Medical History
Current diabetes mellitus
|
37.2 Percentage of participants
n=752 Participants
|
36.2 Percentage of participants
n=748 Participants
|
42.6 Percentage of participants
n=148 Participants
|
37.3 Percentage of participants
n=1648 Participants
|
|
New York Heart Association (NYHA) Classification
Class I
|
0.0 Percentage of participants
n=752 Participants
|
0.0 Percentage of participants
n=748 Participants
|
0.0 Percentage of participants
n=148 Participants
|
0.0 Percentage of participants
n=1648 Participants
|
|
New York Heart Association (NYHA) Classification
Class II
|
50.7 Percentage of participants
n=752 Participants
|
57.8 Percentage of participants
n=748 Participants
|
54.7 Percentage of participants
n=148 Participants
|
54.2 Percentage of participants
n=1648 Participants
|
|
New York Heart Association (NYHA) Classification
Class III
|
47.3 Percentage of participants
n=752 Participants
|
40.4 Percentage of participants
n=748 Participants
|
43.9 Percentage of participants
n=148 Participants
|
43.9 Percentage of participants
n=1648 Participants
|
|
New York Heart Association (NYHA) Classification
Class IV
|
2.0 Percentage of participants
n=752 Participants
|
1.9 Percentage of participants
n=748 Participants
|
1.4 Percentage of participants
n=148 Participants
|
1.9 Percentage of participants
n=1648 Participants
|
|
Operative Risk Group
High/Extreme
|
25.5 Percentage of participants
n=752 Participants
|
28.6 Percentage of participants
n=748 Participants
|
33.8 Percentage of participants
n=148 Participants
|
27.7 Percentage of participants
n=1648 Participants
|
|
Operative Risk Group
Intermediate
|
38.6 Percentage of participants
n=752 Participants
|
36.9 Percentage of participants
n=748 Participants
|
52.7 Percentage of participants
n=148 Participants
|
39.1 Percentage of participants
n=1648 Participants
|
|
Operative Risk Group
Low
|
35.9 Percentage of participants
n=752 Participants
|
34.5 Percentage of participants
n=748 Participants
|
13.5 Percentage of participants
n=148 Participants
|
33.3 Percentage of participants
n=1648 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
|
2.7 Percent
STANDARD_DEVIATION 1.8 • n=752 Participants
|
2.8 Percent
STANDARD_DEVIATION 1.9 • n=748 Participants
|
3.5 Percent
STANDARD_DEVIATION 2.3 • n=148 Participants
|
2.8 Percent
STANDARD_DEVIATION 1.9 • n=1648 Participants
|
|
Aortic Valve Area (AVA)
|
0.67 cm2
STANDARD_DEVIATION 0.14 • n=724 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
0.67 cm2
STANDARD_DEVIATION 0.15 • n=716 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
0.71 cm2
STANDARD_DEVIATION 0.17 • n=140 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
0.68 cm2
STANDARD_DEVIATION 0.15 • n=1580 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
|
Doppler Velocity Index (DVI)
|
0.24 Index
STANDARD_DEVIATION 0.05 • n=731 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
0.24 Index
STANDARD_DEVIATION 0.05 • n=718 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
0.24 Index
STANDARD_DEVIATION 0.06 • n=142 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
0.24 Index
STANDARD_DEVIATION 0.05 • n=1591 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
|
Aortic Valve Mean Pressure Gradient
|
39.6 mmHg
STANDARD_DEVIATION 11.1 • n=734 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
39.4 mmHg
STANDARD_DEVIATION 10.5 • n=726 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
38.7 mmHg
STANDARD_DEVIATION 12.0 • n=142 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
39.4 mmHg
STANDARD_DEVIATION 10.9 • n=1602 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
|
Aortic Valve Peak Velocity
|
4.05 m/s
STANDARD_DEVIATION 0.54 • n=734 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
4.04 m/s
STANDARD_DEVIATION 0.51 • n=726 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
3.99 m/s
STANDARD_DEVIATION 0.57 • n=142 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
4.04 m/s
STANDARD_DEVIATION 0.53 • n=1602 Participants • Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay through 1 year.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.
|
—
|
16.16 percentage of participants
Interval 13.38 to 19.07
|
9.53 percentage of participants
Interval 7.47 to 11.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 days/6 Months/1 Year is defined as subjects who experience an event through 30 days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: all-cause at 6 Months Post-Randomization
|
2 percentage of participants
|
2.7 percentage of participants
|
1.2 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: cardiovascular at 6 Months Post-Randomization
|
2 percentage of participants
|
2.1 percentage of participants
|
0.5 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: non-cardiovascular at 6 Months Post-Randomization
|
0 percentage of participants
|
0.7 percentage of participants
|
0.7 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: all-cause at 1 Year Post-Randomization
|
4.8 percentage of participants
|
5.0 percentage of participants
|
3.9 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: cardiovascular at 1 Year Post-Randomization
|
3.4 percentage of participants
|
3.8 percentage of participants
|
1.8 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: non-cardiovascular at 1 Year Post-Randomization
|
1.4 percentage of participants
|
1.3 percentage of participants
|
2.1 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: all-cause at Discharge/7 Days Post-Randomization
|
0.7 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: cardiovascular at Discharge/7 Days Post-Randomization
|
0.7 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: non-cardiovascular at Discharge/7 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: all-cause at 30 Days Post-Randomization
|
1.4 percentage of participants
|
0.7 percentage of participants
|
0.4 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: cardiovascular at 30 Days Post-Randomization
|
1.4 percentage of participants
|
0.5 percentage of participants
|
0.3 percentage of participants
|
|
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Mortality: non-cardiovascular at 30 Days Post-Randomization
|
0 percentage of participants
|
0.1 percentage of participants
|
0.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of All Stroke: Disabling and Non-disabling
All stroke at Discharge/7 Days Post-Randomization
|
1.4 percentage of participants
|
0.9 percentage of participants
|
1.1 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Disabling stroke at Discharge/7 Days Post-Randomization
|
0.7 percentage of participants
|
0.3 percentage of participants
|
0.7 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Non-disabling stroke at 1 Year Post-Randomization
|
5.5 percentage of participants
|
3.9 percentage of participants
|
2.2 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Non-disabling stroke at Discharge/7 Days Post-Randomization
|
0.7 percentage of participants
|
0.7 percentage of participants
|
0.4 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
All stroke at 30 Days Post-Randomization
|
1.4 percentage of participants
|
1.4 percentage of participants
|
1.4 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Disabling stroke at 1 Year Post-Randomization
|
2.1 percentage of participants
|
1.9 percentage of participants
|
1.3 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Disabling stroke at 30 Days Post-Randomization
|
0.7 percentage of participants
|
0.5 percentage of participants
|
0.8 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Non-disabling stroke at 30 Days Post-Randomization
|
0.7 percentage of participants
|
1.0 percentage of participants
|
0.5 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
All stroke at 6 Months Post-Randomization
|
5.4 percentage of participants
|
4.0 percentage of participants
|
2.5 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Disabling stroke at 6 Months Post-Randomization
|
1.4 percentage of participants
|
1.4 percentage of participants
|
1.0 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
Non-disabling stroke at 6 Months Post-Randomization
|
4.1 percentage of participants
|
2.7 percentage of participants
|
1.5 percentage of participants
|
|
Rate of All Stroke: Disabling and Non-disabling
All stroke at 1 Year Post-Randomization
|
7.5 percentage of participants
|
5.7 percentage of participants
|
3.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
MI at Discharge/7 Days Post-Randomization
|
0.7 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Periprocedural MI at Discharge/7 Days Post-Randomization
|
0.7 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Spontaneous MI at Discharge/7 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
MI at 30 Days Post-Randomization
|
0.7 percentage of participants
|
0.5 percentage of participants
|
0.1 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Periprocedural MI at 30 Days Post-Randomization
|
0.7 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Spontaneous MI at 30 Days Post-Randomization
|
0 percentage of participants
|
0.1 percentage of participants
|
0.1 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
MI at 6 Months Post-Randomization
|
0.7 percentage of participants
|
1.5 percentage of participants
|
0.1 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Periprocedural MI at 6 Months Post-Randomization
|
0.7 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Spontaneous MI at 6 Months Post-Randomization
|
0 percentage of participants
|
1.1 percentage of participants
|
0.1 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
MI at 1 Year Post-Randomization
|
0.7 percentage of participants
|
2.4 percentage of participants
|
0.7 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Periprocedural MI at 1 Year Post-Randomization
|
0.7 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Spontaneous MI at 1 Year Post-Randomization
|
0 percentage of participants
|
1.9 percentage of participants
|
0.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Life-threatening or disabling bleeding at Discharge/7 Days Post-Randomization
|
2.0 percentage of participants
|
1.2 percentage of participants
|
1.2 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Major bleeding at Discharge/7 Days Post-Randomization
|
0 percentage of participants
|
1.2 percentage of participants
|
1.2 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Life-threatening or disabling bleeding at 30 Days Post-Randomization
|
2.0 percentage of participants
|
1.4 percentage of participants
|
1.2 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Major bleeding at 30 Days Post-Randomization
|
0.7 percentage of participants
|
1.6 percentage of participants
|
1.4 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Life-threatening or disabling bleeding at 6 Months Post-Randomization
|
2.0 percentage of participants
|
2.9 percentage of participants
|
2.3 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Major bleeding at 6 Months Post-Randomization
|
2.7 percentage of participants
|
2.2 percentage of participants
|
2.6 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Life-threatening or disabling bleeding at 1 Year Post-Randomization
|
2.7 percentage of participants
|
3.6 percentage of participants
|
3.3 percentage of participants
|
|
Rate of Bleeding: Life-threatening (or Disabling) and Major
Major bleeding at 1 Year Post-Randomization
|
3.4 percentage of participants
|
2.9 percentage of participants
|
3.3 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Major Vascular Complications
Discharge/7 Days Post-Randomization
|
1.4 percentage of participants
|
2.4 percentage of participants
|
1.5 percentage of participants
|
|
Rate of Major Vascular Complications
30 Days Post-Randomization
|
1.4 percentage of participants
|
2.7 percentage of participants
|
1.6 percentage of participants
|
|
Rate of Major Vascular Complications
6 Months Post-Randomization
|
2.0 percentage of participants
|
3.2 percentage of participants
|
2.1 percentage of participants
|
|
Rate of Major Vascular Complications
1 Year Post-Randomization
|
2.1 percentage of participants
|
3.2 percentage of participants
|
2.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)
Discharge/7 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)
30 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)
6 Months Post-Randomization
|
0.7 percentage of participants
|
0.1 percentage of participants
|
0.1 percentage of participants
|
|
Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)
1 Year Post-Randomization
|
0.7 percentage of participants
|
0.1 percentage of participants
|
0.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)
Discharge/7 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)
30 Days Post-Randomization
|
3.4 percentage of participants
|
0.8 percentage of participants
|
0.1 percentage of participants
|
|
Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)
6 Months Post-Randomization
|
4.1 percentage of participants
|
3.7 percentage of participants
|
1.1 percentage of participants
|
|
Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)
1 Year Post-Randomization
|
4.8 percentage of participants
|
5.3 percentage of participants
|
3.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances
Discharge/7 Days Post-Randomization
|
1.4 percentage of participants
|
5.3 percentage of participants
|
6.3 percentage of participants
|
|
Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances
30 Days Post-Randomization
|
4.7 percentage of participants
|
8.6 percentage of participants
|
9.5 percentage of participants
|
|
Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances
6 Months Post-Randomization
|
7.4 percentage of participants
|
10.7 percentage of participants
|
10.9 percentage of participants
|
|
Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances
1 Year Post-Randomization
|
8.2 percentage of participants
|
11.4 percentage of participants
|
12.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial fibrillation at Discharge/7 Days Post-Randomization
|
2.7 percentage of participants
|
1.9 percentage of participants
|
2.1 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial flutter at Discharge/7 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0.1 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial fibrillation at 30 Days Post-Randomization
|
3.4 percentage of participants
|
2.2 percentage of participants
|
2.2 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial flutter at 30 Days Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0.1 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial fibrillation at 6 Months Post-Randomization
|
3.4 percentage of participants
|
2.3 percentage of participants
|
2.3 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial flutter at 6 Months Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0.1 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial fibrillation at 1 Year Post-Randomization
|
3.4 percentage of participants
|
2.4 percentage of participants
|
2.4 percentage of participants
|
|
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial flutter at 1 Year Post-Randomization
|
0 percentage of participants
|
0 percentage of participants
|
0.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, through 7 days post index procedure.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2
Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) or Stage 2
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2
Acute kidney injury based on AKIN System Stage 2
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2
Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed through 72 hours post index procedurePopulation: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) - based on VARC endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Coronary Obstruction: Periprocedural
|
0.7 Percentage of participants
|
0.4 Percentage of participants
|
0.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed through 72 hours post index procedurePopulation: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Ventricular Septal Perforation: Periprocedural
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed through 72 hours post index procedurePopulation: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Mitral Apparatus Damage: Periprocedural
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed through 72 hours post index procedurePopulation: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Cardiac Tamponade: Periprocedural
|
0.7 Percentage of participants
|
0.4 Percentage of participants
|
0.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Valve Migration
Discharge/7 Days Post-Randomization (whichever comes first)
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
0.3 Percentage of participants
|
|
Rate of Valve Migration
30 Days Post-Randomization
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
0.3 Percentage of participants
|
|
Rate of Valve Migration
6 Months Post-Randomization
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
0.3 Percentage of participants
|
|
Rate of Valve Migration
1 Year Post-Randomization
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
0.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Valve Embolization
Discharge/7 Days Post-Randomization (whichever comes first)
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
0.7 Percentage of participants
|
|
Rate of Valve Embolization
30 Days Post-Randomization
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Rate of Valve Embolization
6 Months Post-Randomization
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Rate of Valve Embolization
1 Year Post-Randomization
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure through discharge or 7 days post-procedure (whichever comes first).Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Ectopic Valve Deployment
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
0.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment
Discharge/7 Days Post- Randomization
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.1 Percentage of participants
|
|
Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment
30 Days Post-Randomization
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.1 Percentage of participants
|
|
Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment
6 Months Post-Randomization
|
0.7 Percentage of participants
|
0.7 Percentage of participants
|
0.1 Percentage of participants
|
|
Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment
1 Year Post-Randomization
|
0.7 Percentage of participants
|
0.7 Percentage of participants
|
0.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Prosthetic Aortic Valve Thrombosis
Discharge/7 Days Post-Randomization
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Rate of Prosthetic Aortic Valve Thrombosis
30 Days Post-Randomization
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
|
Rate of Prosthetic Aortic Valve Thrombosis
6 Months Post -Randomization
|
0.0 Percentage of participants
|
0.4 Percentage of participants
|
1.8 Percentage of participants
|
|
Rate of Prosthetic Aortic Valve Thrombosis
1 Year Post-Randomization
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
2.6 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Prosthetic Aortic Valve Endocarditis
Discharge/7 Days Post-Randomization
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Rate of Prosthetic Aortic Valve Endocarditis
30 Days Post-Randomization
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Rate of Prosthetic Aortic Valve Endocarditis
6 Months Post-Randomization
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Rate of Prosthetic Aortic Valve Endocarditis
1 Year Post-Randomization
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
0.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed for the duration of their procedure, an expected average of 1 Day (peri- and post-procedure)Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Device Performance outcome, as measured by site reported data based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment)
|
100.0 Percentage of participants
|
98.6 Percentage of participants
|
99.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Mild
|
37.6 percentage of participants
|
40.8 percentage of participants
|
28.2 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Moderate
|
4.3 percentage of participants
|
4.4 percentage of participants
|
0.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Severe
|
0 percentage of participants
|
0.2 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace
|
64.2 percentage of participants
|
52.6 percentage of participants
|
73.4 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 1 Year Post-Procedure - Mild
|
32.5 percentage of participants
|
42.5 percentage of participants
|
24.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate
|
3.3 percentage of participants
|
4.4 percentage of participants
|
1.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 1 Year Post-Procedure - Severe
|
0 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace
|
95.9 percentage of participants
|
95.0 percentage of participants
|
99.4 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 1 Year Post-Procedure - Mild
|
4.1 percentage of participants
|
4.7 percentage of participants
|
0.6 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 1 Year Post-Procedure - Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - None/Trace
|
66.7 percentage of participants
|
55.5 percentage of participants
|
74.0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Mild
|
30.9 percentage of participants
|
40.7 percentage of participants
|
24.2 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Moderate
|
2.4 percentage of participants
|
3.2 percentage of participants
|
1.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Severe
|
0 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace
|
68.5 percentage of participants
|
74.9 percentage of participants
|
85.9 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild
|
29.5 percentage of participants
|
23.9 percentage of participants
|
13.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate
|
2.1 percentage of participants
|
1.1 percentage of participants
|
0.3 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe
|
0 percentage of participants
|
0.1 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace
|
97.3 percentage of participants
|
98.8 percentage of participants
|
99.9 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild
|
2.7 percentage of participants
|
1.2 percentage of participants
|
0.1 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - None/Trace
|
70.5 percentage of participants
|
75.9 percentage of participants
|
86.1 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Mild
|
28.1 percentage of participants
|
23.0 percentage of participants
|
13.6 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Moderate
|
1.4 percentage of participants
|
1.0 percentage of participants
|
0.3 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Severe
|
0 percentage of participants
|
0.1 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace
|
52.2 percentage of participants
|
57.1 percentage of participants
|
75.5 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 30 Days Post-Procedure - Mild
|
44.9 percentage of participants
|
38.6 percentage of participants
|
23.5 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate
|
2.9 percentage of participants
|
4.1 percentage of participants
|
1.0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 30 Days Post-Procedure - Severe
|
0 percentage of participants
|
0.1 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace
|
97.1 percentage of participants
|
97.7 percentage of participants
|
99.9 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 30 Days Post-Procedure - Mild
|
2.9 percentage of participants
|
2.2 percentage of participants
|
0.1 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate
|
0 percentage of participants
|
0.1 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 30 Days Post-Procedure - Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - None/Trace
|
54.3 percentage of participants
|
58.5 percentage of participants
|
75.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Mild
|
42.8 percentage of participants
|
38.1 percentage of participants
|
23.2 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Moderate
|
2.9 percentage of participants
|
3.3 percentage of participants
|
1.0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Severe
|
0 percentage of participants
|
0.1 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace
|
57.3 percentage of participants
|
53.0 percentage of participants
|
70.1 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 6 Months Post-Procedure - Mild
|
38.5 percentage of participants
|
41.8 percentage of participants
|
29.2 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate
|
4.3 percentage of participants
|
5.1 percentage of participants
|
0.8 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Total aortic regurgitation (AR) at 6 Months Post-Procedure - Severe
|
0 percentage of participants
|
0.2 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace
|
96.6 percentage of participants
|
96.6 percentage of participants
|
99.0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 6 Months Post-Procedure - Mild
|
3.4 percentage of participants
|
3.1 percentage of participants
|
1.0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Central aortic regurgitation (AR) at 6 Months Post-Procedure - Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - None/Trace
|
58.1 percentage of participants
|
54.6 percentage of participants
|
71.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed for the duration of their procedure, an expected average of 1 Day (post-procedure)Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area \[iEOA\] \>0.85 cm2/m2 for BMI \<30 kg/cm2 and iEOA \>0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient \<20 mmHg or a peak velocity \< 3m, and no moderate or severe prosthetic valve aortic regurgitation) based on VARC-2 endpoints and definitions.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Rate of Device Success
Device Success
|
57.0 Percentage of participants
|
74.1 Percentage of participants
|
81.8 Percentage of participants
|
|
Rate of Device Success
Absence of procedural mortality
|
100.0 Percentage of participants
|
99.6 Percentage of participants
|
100.0 Percentage of participants
|
|
Rate of Device Success
Correct positioning of a single valve into the proper anatomical location
|
100.0 Percentage of participants
|
98.4 Percentage of participants
|
99.1 Percentage of participants
|
|
Rate of Device Success
Intended performance of the study device
|
57.0 Percentage of participants
|
75.8 Percentage of participants
|
82.5 Percentage of participants
|
|
Rate of Device Success
iEOA >0.85 cm2/m2 for BMI <30 kg/m2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/m2 (AND)
|
60.4 Percentage of participants
|
77.0 Percentage of participants
|
83.7 Percentage of participants
|
|
Rate of Device Success
Mean aortic valve gradient <20 mmHg OR peak velocity <3m/sec (AND)
|
96.5 Percentage of participants
|
99.0 Percentage of participants
|
98.3 Percentage of participants
|
|
Rate of Device Success
No moderate or severe prosthetic valve aortic regurgitation
|
97.9 Percentage of participants
|
98.8 Percentage of participants
|
99.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Effective Orifice Area (EOA)
1 Year Post-Procedure
|
1.64 cm2
Standard Deviation 0.32
|
1.77 cm2
Standard Deviation 0.28
|
1.78 cm2
Standard Deviation 0.30
|
|
Effective Orifice Area (EOA)
6 Months Post-Procedure
|
1.65 cm2
Standard Deviation 0.31
|
1.76 cm2
Standard Deviation 0.28
|
1.77 cm2
Standard Deviation 0.31
|
|
Effective Orifice Area (EOA)
Discharge/7 Days Post-Procedure
|
1.68 cm2
Standard Deviation 0.34
|
1.77 cm2
Standard Deviation 0.3
|
1.82 cm2
Standard Deviation 032
|
|
Effective Orifice Area (EOA)
30 Days Post-Procedure
|
1.65 cm2
Standard Deviation 0.34
|
1.76 cm2
Standard Deviation 0.29
|
1.78 cm2
Standard Deviation 0.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
Mean Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Mean Aortic Gradient
Discharge/7 Days Post-Procedure
|
10.0 mmHg
Standard Deviation 4.7
|
9.0 mmHg
Standard Deviation 3.9
|
10.2 mmHg
Standard Deviation 4.2
|
|
Mean Aortic Gradient
30 Days Post-Procedure
|
8.1 mmHg
Standard Deviation 3.3
|
8 mmHg
Standard Deviation 3.2
|
10.1 mmHg
Standard Deviation 4.7
|
|
Mean Aortic Gradient
6 Months Post-Procedure
|
8.1 mmHg
Standard Deviation 4.0
|
8.1 mmHg
Standard Deviation 3.3
|
10.6 mmHg
Standard Deviation 5.1
|
|
Mean Aortic Gradient
1 Year Post-Procedure
|
8.4 mmHg
Standard Deviation 3.4
|
7.9 mmHg
Standard Deviation 3.3
|
10.7 mmHg
Standard Deviation 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. NYHA class denominator is the number of subjects with non-missing NYHA class at the studied timepoint.
Health status evaluated by New York Heart Association (NYHA) Classification. NYHA Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
New York Heart Association (NYHA) Functional Status Classification
Discharge/7 Days Post Procedure NYHA Functional Class - I
|
32.7 Percentage of participants
|
34.1 Percentage of participants
|
32.0 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
Discharge/7 Days Post-Procedure NYHA Functional Class - II
|
49.0 Percentage of participants
|
49.4 Percentage of participants
|
52.4 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
Discharge/7 Days Post-Procedure NYHA Functional Class - III
|
18.4 Percentage of participants
|
15.8 Percentage of participants
|
15.5 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
Discharge/7 Days Post-Procedure NYHA Functional Class - IV
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.1 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
30 Days Post-Procedure NYHA Functional Class - I
|
57.2 Percentage of participants
|
57.7 Percentage of participants
|
60.1 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
30 Days Post-Procedure NYHA Functional Class - II
|
39.3 Percentage of participants
|
37.8 Percentage of participants
|
35.0 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
30 Days Post-Procedure NYHA Functional Class - III
|
3.4 Percentage of participants
|
4.3 Percentage of participants
|
4.9 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
30 Days Post-Procedure NYHA Functional Class - IV
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
6 Months Post-Procedure NYHA Functional Class - I
|
64.4 Percentage of participants
|
65.1 Percentage of participants
|
66.2 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
6 Months Post-Procedure NYHA Functional Class - II
|
31.1 Percentage of participants
|
29.9 Percentage of participants
|
29.3 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
6 Months Post-Procedure NYHA Functional Class - III
|
4.5 Percentage of participants
|
4.6 Percentage of participants
|
4.4 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
6 Months Post-Procedure NYHA Functional Class - IV
|
0.0 Percentage of participants
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
1 Year Post-Procedure NYHA Functional Class - I
|
60.3 Percentage of participants
|
64.9 Percentage of participants
|
64.4 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
1 Year Post-Procedure NYHA Functional Class - II
|
35.7 Percentage of participants
|
31.9 Percentage of participants
|
31.1 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
1 Year Post-Procedure NYHA Functional Class - III
|
4.0 Percentage of participants
|
3.0 Percentage of participants
|
4.4 Percentage of participants
|
|
New York Heart Association (NYHA) Functional Status Classification
1 Year Post-Procedure NYHA Functional Class - IV
|
0.0 Percentage of participants
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Note: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.
Health Status additional outcome KCCQ Analysis - Overall Summary Score change from Baseline. Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Overall Summary Score - mean of score 1, 5, 7, and 8
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline
Change from Baseline to 1 Year - Overall Summary Score
|
19.8 Score on a scale
Standard Deviation 20.8
|
19.4 Score on a scale
Standard Deviation 22.2
|
20.0 Score on a scale
Standard Deviation 22.1
|
|
Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline
Baseline - Overall Summary Score
|
62.0 Score on a scale
Standard Deviation 21.5
|
62.4 Score on a scale
Standard Deviation 22.3
|
62.2 Score on a scale
Standard Deviation 21.9
|
|
Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline
Change from Baseline to 30 Days - Overall Summary Score
|
19.8 Score on a scale
Standard Deviation 21.1
|
18.1 Score on a scale
Standard Deviation 21.6
|
17.8 Score on a scale
Standard Deviation 22.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.Population: Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment. Note: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.
Health Status outcome - SF-12 - Baseline scores and changes from Baseline at 30 Days and 1 Year. 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
ACURATE neo2 Valve - Single-arm Roll-in
n=148 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
ACURATE neo2 Valve - Main Randomized
n=752 Participants
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 Participants
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
|---|---|---|---|
|
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Baseline - Physical Summary Score
|
36.4 Score on a scale
Standard Deviation 10.2
|
36.9 Score on a scale
Standard Deviation 10.7
|
36.1 Score on a scale
Standard Deviation 11.0
|
|
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Baseline - Mental Health Summary Score
|
51.6 Score on a scale
Standard Deviation 9.1
|
51.7 Score on a scale
Standard Deviation 10.0
|
51.8 Score on a scale
Standard Deviation 10.3
|
|
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Change from Baseline to 30 Days - Physical Summary Score
|
5.7 Score on a scale
Standard Deviation 10.6
|
4.8 Score on a scale
Standard Deviation 9.9
|
5.4 Score on a scale
Standard Deviation 10.5
|
|
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Change from Baseline to 30 Days - Mental Health Summary Score
|
3.2 Score on a scale
Standard Deviation 10.7
|
2.8 Score on a scale
Standard Deviation 11.1
|
2.3 Score on a scale
Standard Deviation 11.1
|
|
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Change from Baseline to 1 Year - Physical Summary Score
|
4.8 Score on a scale
Standard Deviation 10.2
|
5.2 Score on a scale
Standard Deviation 11.0
|
5.4 Score on a scale
Standard Deviation 11.5
|
|
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Change from Baseline to 1 Year - Mental Health Summary Score
|
1.6 Score on a scale
Standard Deviation 10.4
|
2.0 Score on a scale
Standard Deviation 10.8
|
2.1 Score on a scale
Standard Deviation 11.1
|
Adverse Events
ACURATE neo2 Valve - Main Randomized
Serious events: 389 serious events
Other events: 155 other events
Deaths: 36 deaths
Commercial Valve - Main Randomized
Serious events: 381 serious events
Other events: 145 other events
Deaths: 28 deaths
ACURATE neo2 Valve - Single-arm Roll-in
Serious events: 81 serious events
Other events: 26 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
ACURATE neo2 Valve - Main Randomized
n=752 participants at risk
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 participants at risk
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System.
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
ACURATE neo2 Valve - Single-arm Roll-in
n=148 participants at risk
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
|---|---|---|---|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Ascites
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Colitis
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Faecaloma
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Gastric ileus
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.93%
7/752 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.1%
8/748 • Number of events 10 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Ileus
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Melaena
|
0.13%
1/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Nausea
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.13%
1/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Asthenia
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Catheter site haematoma
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Catheter site haemorrhage
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Catheter site pain
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Catheter site thrombosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Chest pain
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Complication associated with device
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Cyst
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Death
|
1.5%
11/752 • Number of events 11 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Device embolisation
|
0.93%
7/752 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Gait disturbance
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Hypothermia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Non-cardiac chest pain
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Pyrexia
|
0.66%
5/752 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Immune system disorders
Contrast media allergy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Immune system disorders
Hypersensitivity
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Abdominal wall infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Arthritis bacterial
|
0.27%
2/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Bacteraemia
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Bronchitis
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Catheter site infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Cellulitis
|
0.93%
7/752 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
3.4%
5/148 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Chronic sinusitis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Clostridial sepsis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Corona virus infection
|
1.6%
12/752 • Number of events 12 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.94%
7/748 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Cystitis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Device related infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Diverticulitis
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Endocarditis
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Endocarditis bacterial
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Epididymitis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Gangrene
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Haematoma infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Implant site infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Influenza
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Localised infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Osteomyelitis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Osteomyelitis acute
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Pneumonia
|
2.0%
15/752 • Number of events 16 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.5%
19/748 • Number of events 19 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
3.4%
5/148 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Postoperative wound infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Sepsis
|
1.2%
9/752 • Number of events 9 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.9%
14/748 • Number of events 16 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
3.4%
5/148 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Septic shock
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Soft tissue infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Staphylococcal infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Streptococcal infection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Streptococcal sepsis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
17/752 • Number of events 19 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.3%
10/748 • Number of events 10 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Device deployment issue
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
11/752 • Number of events 11 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.0%
3/148 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Structural valve deterioration
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.40%
3/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Trunk injury
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.53%
4/752 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.0%
3/148 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm thrombosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Bleeding time prolonged
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
CSF test abnormal
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Echocardiogram abnormal
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
International normalised ratio increased
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Lactescent serum
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Pedal pulse decreased
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
Troponin increased
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Investigations
White blood cell count increased
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
1/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
6/752 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute megakaryocytic leukaemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.53%
4/752 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine neoplasm
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Product Issues
Device failure
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Aphasia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cerebellar stroke
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.40%
3/752 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.7%
28/752 • Number of events 30 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.6%
12/748 • Number of events 12 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
4.1%
6/148 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Chorea
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Dementia
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Dizziness
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Dysarthria
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Encephalopathy
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Facial paralysis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Hemiparesis
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Hyponatraemic encephalopathy
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.80%
6/752 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Lethargy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Multiple system atrophy
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Myelopathy
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Paralysis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Parkinson's disease
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Periventricular leukomalacia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Presyncope
|
1.1%
8/752 • Number of events 8 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Seizure
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Syncope
|
1.1%
8/752 • Number of events 9 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
4.1%
6/148 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
12/752 • Number of events 13 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.94%
7/748 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Tremor
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Product Issues
Device dislocation
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Product Issues
Device leakage
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Product Issues
Device occlusion
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Psychiatric disorders
Delirium
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Psychiatric disorders
Mental status changes
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Psychiatric disorders
Substance abuse
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
22/752 • Number of events 26 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.3%
17/748 • Number of events 18 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
4.7%
7/148 • Number of events 8 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
End stage renal disease
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Haematuria
|
0.53%
4/752 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.40%
3/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Renal failure
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.13%
1/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Urinary retention
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
9/752 • Number of events 9 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.80%
6/752 • Number of events 8 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
11/752 • Number of events 12 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.3%
17/748 • Number of events 18 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Air embolism
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Angiopathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Aortic aneurysm
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Aortic dissection
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Arterial rupture
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Arteriovenous fistula
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
3/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Distributive shock
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Femoral artery dissection
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Haematoma
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Haemodynamic instability
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Haemorrhage
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Hypertension
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Hypertensive crisis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Hypertensive emergency
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Hypotension
|
2.0%
15/752 • Number of events 15 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Hypovolaemic shock
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Iliac artery perforation
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Intermittent claudication
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Paradoxical embolism
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral artery dissection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.80%
6/752 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral ischaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Shock
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Subclavian artery aneurysm
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Thrombosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Vascular calcification
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
10/752 • Number of events 10 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.7%
4/148 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Cold type haemolytic anaemia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Acute left ventricular failure
|
1.6%
12/752 • Number of events 13 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
13/752 • Number of events 13 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Angina unstable
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Aortic valve thickening
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
32/752 • Number of events 37 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
5.1%
38/748 • Number of events 40 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
4.7%
7/148 • Number of events 11 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrial flutter
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrioventricular block
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrioventricular block complete
|
6.9%
52/752 • Number of events 53 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
9.1%
68/748 • Number of events 70 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
4.7%
7/148 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.66%
5/752 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.94%
7/748 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.93%
7/752 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Bradycardia
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.2%
9/748 • Number of events 9 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Bundle branch block left
|
4.3%
32/752 • Number of events 32 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
4.0%
30/748 • Number of events 30 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Bundle branch block right
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
11/752 • Number of events 11 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiac failure
|
0.93%
7/752 • Number of events 8 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.1%
8/748 • Number of events 9 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiac failure acute
|
1.2%
9/752 • Number of events 10 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.1%
8/748 • Number of events 8 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.0%
3/148 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.9%
22/752 • Number of events 28 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
2.5%
19/748 • Number of events 22 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
5.4%
8/148 • Number of events 11 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiac perforation
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiogenic shock
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiomegaly
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Cardiomyopathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Conduction disorder
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Coronary artery disease
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.53%
4/748 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Coronary artery dissection
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Hyperdynamic left ventricle
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Left ventricular failure
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.66%
5/752 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Myocardial infarction
|
0.93%
7/752 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.40%
3/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Myocarditis
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Nodal rhythm
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Palpitations
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Paravalvular aortic regurgitation
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Pericardial effusion
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Prosthetic cardiac valve thrombosis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.80%
6/748 • Number of events 6 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Sinus arrest
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.94%
7/748 • Number of events 7 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.27%
2/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.67%
5/748 • Number of events 5 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
1.4%
2/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.40%
3/752 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.53%
4/752 • Number of events 4 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.40%
3/748 • Number of events 3 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Congenital, familial and genetic disorders
Skin malformation
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Cataract
|
0.27%
2/752 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Cataract nuclear
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Glaucoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Iritis
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Photophobia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Retinal infarction
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.68%
1/148 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.27%
2/748 • Number of events 2 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.13%
1/752 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.13%
1/748 • Number of events 1 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/148 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
Other adverse events
| Measure |
ACURATE neo2 Valve - Main Randomized
n=752 participants at risk
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
|
Commercial Valve - Main Randomized
n=748 participants at risk
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System.
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
|
ACURATE neo2 Valve - Single-arm Roll-in
n=148 participants at risk
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
6.5%
49/752 • Number of events 50 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
6.4%
48/748 • Number of events 48 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
6.1%
9/148 • Number of events 9 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
Cardiac disorders
Bundle branch block left
|
16.1%
121/752 • Number of events 122 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
14.8%
111/748 • Number of events 114 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
8.8%
13/148 • Number of events 13 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/752 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
0.00%
0/748 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
5.4%
8/148 • Number of events 8 • 1 Year
Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure. Events are reported for the ITT population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PIs and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER