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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)
|
| 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 |
| Actual Number of Patients Enrolled |
Native Aortic Valve Stenosis Cohort: 1,215 procedures attempted; 1,213 patients implanted; THV in Failing Aortic Surgical Valve Cohort: 32 procedures attempted; 32 patients implanted; THV in Failing Aortic Transcatheter Valve Cohort: 12 procedures attempted; 12 patients implanted; THV in Failing Mitral Surgical Valve Cohort: 21 procedures attempted; 21 patients implanted; THV in Failing Mitral Ring Cohort: 6 procedures attempted; 6 patients implanted.
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| Actual Number of Sites Enrolled |
Native Aortic Valve Stenosis Cohort: 178 sites; THV in Failing Aortic Surgical Valve Cohort: 23 sites; THV in Failing Aortic Transcatheter Valve Cohort: 8 sites; THV in Failing Mitral Surgical Valve Cohort: 18 sites; THV in Failing Mitral Ring Cohort: 3 sites.
|
| Patient Follow-up Rate |
At 30 days:
Native Aortic Valve Stenosis Cohort:
Patient status known: 88.9% (1080/1215)
THV in Failing Aortic Surgical Valve Cohort:
Patient status known: 93.8% (30/32)
THV in Failing Aortic Transcatheter Valve Cohort:
Patient status known: 91.7% (11/12)
THV in Failing Mitral Surgical Valve Cohort:
Patient status known: 90.5% (19/21)
THV in Failing Mitral Ring Cohort:
Due to the limited amount of data for this cohort, data was not tabulated for this reporting peri
|
| Final Safety Findings |
K-M Rates At 30 Days:
Native Aortic Valve Stenosis Cohort (n=1215):
All-cause death: 1.7%; All strokes: 1.8%; Aortic valve reintervention: 0.2%
THV in Failing Aortic Surgical Valve Cohort (n=32):
The K-M rates are not reported due to the limited amount of data for this cohort. Event Counts are provided below.
All-cause death: 0; All strokes: 0; Aortic valve reintervention: 0
THV in Failing Aortic Transcatheter Valve Cohort (n=12):
The K-M rates are not reported due to the limited amount of data for this cohort. Event Counts are provided below.
All-cause death: 0; All strokes: 0; Aortic valve reintervention: 0
THV in Failing Mitral Surgical Valve Cohort (n=21):
The K-M rates are not reported due to the limited amount of data for this cohort. Event Counts are provided below.
All-cause death: 0; All strokes: 1; Mitral valve reintervention: 0
THV in Failing Mitral Ring Cohort (n=6):
Due to the limited amount of data for this cohort, data was not tabulated for this reporting period.
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| Final Effect Findings |
KCCQ Overall Summary Score
(Change from baseline to 30-day visit):
Native Aortic Valve Stenosis Cohort: 25.9 -/+ 0.90 (n=830).
THV in Failing Aortic Surgical Valve Cohort: 41.3 -/+ 7.0 (n=23)
THV in Failing Aortic Transcatheter Valve Cohort:
58.0 -/+ 14.26 (n=6)
THV in Failing Mitral Surgical Valve Cohort:
44.8 -/+ 8.79 (n=15)
THV in Failing Mitral Ring Cohort:
Due to the limited amount of data for this cohort, data was not tabulated for this reporting period.
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