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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S141/ PAS001 |
| Date Original Protocol Accepted |
09/23/2022
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| Date Current Protocol Accepted |
|
| Study Name |
S3UR Real World Surveillance
|
| Device Name |
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to assess the real-world performance of the SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve.
|
| Study Population |
The surveillance will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
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| Sample Size |
All consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
|
| Key Study Endpoints |
(1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening /major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-10 year post-implantation.
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| Follow-up Visits and Length of Follow-up |
10 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Native Aortic Valve Stenosis Cohort: 25,002 procedures attempted; 24,962 patients implanted; THV in Failing Aortic Surgical Valve Cohort: 708 procedures attempted; 706 patients implanted; THV in Failing Aortic Transcatheter Valve Cohort: 232 procedures attempted; 232 patients implanted; THV in Failing Mitral Surgical Valve Cohort: 354 procedures attempted; 351 patients implanted; THV in Failing Mitral Ring Cohort: 71 procedures attempted; 70 patients implanted.
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| Actual Number of Sites Enrolled |
Native Aortic Valve Stenosis Cohort: 573 sites; THV in Failing Aortic Surgical Valve Cohort: 214 sites; THV in Failing Aortic Transcatheter Valve Cohort: 127 sites; THV in Failing Mitral Surgical Valve Cohort: 145 sites; THV in Failing Mitral Ring Cohort: 48 sites.
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| Patient Follow-up Rate |
At 30 days:
Native Aortic Valve Stenosis Cohort:
Patient status known: 94.3% (23573/25002)
THV in Failing Aortic Surgical Valve Cohort:
Patient status known: 94.5% (669/708)
THV in Failing Aortic Transcatheter Valve Cohort:
Patient status known: 95.3% (221/232)
THV in Failing Mitral Surgical Valve Cohort:
Patient status known: 92.4% (327/354)
THV in Failing Mitral Ring Cohort:
Patient status known: 87.3% (62/71)
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| Final Safety Findings |
K-M Rates At 30 Days:
Native Aortic Valve Stenosis Cohort (n=25002):
All-cause death: 1.3%; All strokes: 1.7%; Aortic valve reintervention: 0.1%
THV in Failing Aortic Surgical Valve Cohort (n=708):
All-cause death: 3.5%; All strokes: 1.9%; Aortic valve reintervention: 0.4%
THV in Failing Aortic Transcatheter Valve Cohort (n=232):
All-cause death: 3.5%; All strokes: 3.5%; Aortic valve reintervention: 0.0%
THV in Failing Mitral Surgical Valve Cohort (n=354):
All-cause death: 3.5%; All strokes: 1.5%; Mitral valve reintervention: 0.6%
THV in Failing Mitral Ring Cohort (n=71):
All-cause death: 6.2%; All strokes: 3.1%; Mitral valve reintervention: 9.4%
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| Final Effect Findings |
KCCQ Overall Summary Score
(Change from baseline to 30-day visit):
Native Aortic Valve Stenosis Cohort: 26.3 +/- 0.19 (n=18258).
THV in Failing Aortic Surgical Valve Cohort: 38.0 +/- 1.34 (n=485)
THV in Failing Aortic Transcatheter Valve Cohort:
38.9 +/- 2.27 (n=135)
THV in Failing Mitral Surgical Valve Cohort:
41.6 +/- 1.99 (n=208)
THV in Failing Mitral Ring Cohort:
26.3 +/- 5.40 (n=35)
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