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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 |
09/23/2022
|
| Study Name |
S3UR Real World Surveillance
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| 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
|
| 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.
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| 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 |
| Interim Results |
Safety Results:
K-M Rates:
Native Aortic Valve Stenosis Cohort (n=46,391):
30-days: All-cause death: 1.3%; All strokes: 1.7%; Aortic valve reintervention: 0.1%
1-year: All-cause death: 8.3%; All strokes: 3.2%; Aortic valve reintervention: 0.4%
THV in Failing Aortic Surgical Valve Cohort (n=1,3024:
30-days: All-cause death: 3.0%; All strokes: 2.3%; Aortic valve reintervention: 0.4%
1-year: All-cause death: 8.8%; All strokes: 3.4%; Aortic valve reintervention: 0.8%
THV in Failing Aortic Transcatheter Valve Cohort (n=451):
30-days: All-cause death: 3.6%; All strokes: 2.5%; Aortic valve reintervention: 0.2%
1-year: All-cause death: 16.8%; All strokes: 4.0%; Aortic valve reintervention: 0.7%
THV in Failing Mitral Surgical Valve Cohort (n=674):
30-days: All-cause death: 3.5%; All strokes: 1.1%; Mitral valve reintervention: 0.3%
1-year: All-cause death: 12.4%; All strokes: 3.5%; Mitral valve reintervention: 1.3%
THV in Failing Mitral Ring Cohort (n=137):
30-days: All-cause death: 2.9%; All strokes: 2.2%; Mitral valve reintervention: 8.1%
1-year: All-cause death: 15.0%; All strokes: 4.1%; Mitral valve reintervention: 11%
Effectiveness Results:
KCCQ Overall Summary Score
(Change from baseline to 30-day/1-year visit):
Native Aortic Valve Stenosis Cohort:
30-days: 26.1 + 0.14 (n=34,661); 1-year: 28.0 + 0.17 (n=23,902)
THV in Failing Aortic Surgical Valve Cohort:
30-days: 38.5 + 0.96 (n=902); 1-year: 41.0 + 1.15 (n=620)
THV in Failing Aortic Transcatheter Valve Cohort:
30-days: 38.5 + 1.75 (n=282); 1-year: 42.5 + 2.32 (n=164)
THV in Failing Mitral Surgical Valve Cohort:
30-days: 37.3 + 1.49 (n=401); 1-year: 38.7 + 1.64 (n=244)
THV in Failing Mitral Ring Cohort:
30-days: 21.2 + 3.14 (n=78); 1-year: 21.4 + 4.41 (n=41)
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| Actual Number of Patients Enrolled |
Native Aortic Valve Stenosis Cohort: 46,391 procedures attempted; 46,310 patients implanted; THV in Failing Aortic Surgical Valve Cohort: 1,304 procedures attempted; 1,301 patients implanted; THV in Failing Aortic Transcatheter Valve Cohort: 451 procedures attempted; 451 patients implanted; THV in Failing Mitral Surgical Valve Cohort: 674 procedures attempted; 669 patients implanted; THV in Failing Mitral Ring Cohort: 137 procedures attempted; 136 patients implanted.
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| Actual Number of Sites Enrolled |
Native Aortic Valve Stenosis Cohort: 677 sites; THV in Failing Aortic Surgical Valve Cohort: 313 sites; THV in Failing Aortic Transcatheter Valve Cohort: 206 sites; THV in Failing Mitral Surgical Valve Cohort: 209 sites; THV in Failing Mitral Ring Cohort: 81 sites.
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| Patient Follow-up Rate |
Native Aortic Valve Stenosis Cohort:
Patient status known: 30 days: 97.4% (45,196/46,391);
1-year: 84.1% (39,023/46,391)
THV in Failing Aortic Surgical Valve Cohort:
Patient status known: 30 days: 97.2% (1,268/1,304);
1-year: 85.3% (1,112/1,304)
THV in Failing Aortic Transcatheter Valve Cohort:
Patient status known: 30 days: 97.3% (439/451);
1-year: 84.7% (382/451)
THV in Failing Mitral Surgical Valve Cohort:
Patient status known: 30 days: 96.3% (649/674);
1-year: 82.2% (554/674)
THV in Failing Mitral Ring Cohort:
Patient status known: 30 days: 98.5% (135/137);
1-year: 89.1% (122/137)
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