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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S162/ PAS001 |
| Date Original Protocol Accepted |
05/23/2024
|
| Date Current Protocol Accepted |
|
| Study Name |
Intermediate Risk Indication Real-World Use Surv
|
| Device Name |
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems
|
| Clinical Trial Number(s) |
NCT03193801
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the surveillance is to assess the real-world performance of the SAPIEN 3 platform for the mitral valve-in-valve intermediate-risk indication.
|
| Study Population |
Adults
|
| Sample Size |
All patients entered into the TVT Registry database with a failing surgical mitral valve (stenosed, insufficient, or combined) who are judged by a heart team to be at intermediate risk for open surgical therapy and treated with the SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra RESILIA THV Systems within the first 3 years after the date of PMA approval or a total of 1,000 treated patients, whichever is greater. Data collection will continue for underrepresented racial and ethnic groups until each group has enrolled the following minimum number of patients: 150 Hispanic, 150 Black/African American, 100 Asian, 50 American Indian/Alaskan Native, 25 Native Hawaiian/Pacific Islander.
|
| Key Study Endpoints |
Intra-Procedural: Device implanted successfully; 30 Days and 1 year: All-cause mortality, all stroke, life threatening/major bleeding, new requirement for dialysis, myocardial infarction, mitral valve reintervention, TIA, vascular complications, 6-minute walk distance, Quality of life (KCCQ), change in NYHA functional class from baseline, mitral valve hemodynamics; Annually years 2-10: all-cause mortality, all stroke, mitral valve reintervention.
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| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Device implanted successfully: 98.8%
At 30-days:
All-cause mortality: 1.5%
All-stroke: 0%
Life-threatening/major bleeding: 1.4%
New requirement for dialysis: 0%
Myocardial infarction: 0%
Mitral valve reintervention: 0%
TIA: 0%
Vascular complications: 5.1%
Effectiveness Results:
At 30-days:
Improvement from baseline in NYHA functional classification: 82.6%
KCCQ Overall Summary Score change from baseline: 29.4
Mitral valve area: 2.05 cm2
Mean Mitral Gradient: 6.0 mmHg
Moderate or greater Paravalvular Mitral Regurgitation: 0%
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| Actual Number of Patients Enrolled |
A total of 84 patients were treated. All patients were included in the VI population.
|
| Actual Number of Sites Enrolled |
72
|
| Patient Follow-up Rate |
Patient status known at 30 days is 84.5%
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