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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S141/ PAS001 |
| Date Original Protocol Accepted |
09/23/2022
|
| Date Current Protocol Accepted |
09/23/2022
|
| 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)
|
| 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
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
K-M Rates At 30 Days:
Native Aortic Valve Stenosis Cohort (n=46,367):
All-cause death: 1.3%; All strokes: 1.7%; Aortic valve reintervention: 0.1%
THV in Failing Aortic Surgical Valve Cohort (n=1,302):
All-cause death: 3.1%; All strokes: 2.3%; Aortic valve reintervention: 0.4%
THV in Failing Aortic Transcatheter Valve Cohort (n=450):
All-cause death: 3.4%; All strokes: 2.5%; Aortic valve reintervention: 0.2%
THV in Failing Mitral Surgical Valve Cohort (n=671):
All-cause death: 3.5%; All strokes: 1.1%; Mitral valve reintervention: 0.3%
THV in Failing Mitral Ring Cohort (n=136):
All-cause death: 3.0%; All strokes: 2.2%; Mitral valve reintervention: 8.2%
Effectiveness Results:
KCCQ Overall Summary Score
(Change from baseline to 30-day visit):
Native Aortic Valve Stenosis Cohort: 26.1 +/- 0.14 (n=34,626)
THV in Failing Aortic Surgical Valve Cohort: 38.5 +/- 0.96 (n=900)
THV in Failing Aortic Transcatheter Valve Cohort:
38.3 +/- 1.76 (n=280)
THV in Failing Mitral Surgical Valve Cohort:
37.5 +/- 1.49 (n=398)
THV in Failing Mitral Ring Cohort:
20.6 +/- 3.09 (n=78)
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| Actual Number of Patients Enrolled |
Native Aortic Valve Stenosis Cohort: 46,367 procedures attempted; 46,286 patients implanted; THV in Failing Aortic Surgical Valve Cohort: 1,302 procedures attempted; 1,299 patients implanted; THV in Failing Aortic Transcatheter Valve Cohort: 450 procedures attempted; 450 patients implanted; THV in Failing Mitral Surgical Valve Cohort: 671 procedures attempted; 666 patients implanted; THV in Failing Mitral Ring Cohort: 136 procedures attempted; 135 patients implanted.
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| Actual Number of Sites Enrolled |
Native Aortic Valve Stenosis Cohort: 676 sites; THV in Failing Aortic Surgical Valve Cohort: 312 sites; THV in Failing Aortic Transcatheter Valve Cohort: 206 sites; THV in Failing Mitral Surgical Valve Cohort: 207 sites; THV in Failing Mitral Ring Cohort: 80 sites.
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| Patient Follow-up Rate |
At 30 days:
Native Aortic Valve Stenosis Cohort:
Patient status known: 96.6% (44,799/46,367)
THV in Failing Aortic Surgical Valve Cohort:
Patient status known: 96.5% (1,257/1,302)
THV in Failing Aortic Transcatheter Valve Cohort:
Patient status known: 95.6% (430/450)
THV in Failing Mitral Surgical Valve Cohort:
Patient status known: 95.1% (638/671)
THV in Failing Mitral Ring Cohort:
Patient status known: 97.8% (133/136)
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