|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S028/ PAS002 |
| Date Original Protocol Accepted |
11/20/2017
|
| Date Current Protocol Accepted |
|
| Study Name |
SAPIEN 3 Mitral Valve-in-Valve Comp Surv
|
| Device Name |
Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Patients will be enrolled into the TVT registry for the 2 years following device approval (from June 5, 2017 to June 4, 2019). All patients enrolled in the registry will be followed by the registry for the first year and then linked to CMS claims data for follow-up through five years.
The data collected through this surveillance plan will be submitted to the FDA bi-annually for the first 2 years after device approval and annually until the last enrolled patients reaches 5 years.
|
| Study Population |
Patients with symptomatic heart disease due to a failed bioprosthetic mitral valve (stenosed, insufficient or combined) who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
|
| Sample Size |
Enrollment will consist of all patients with SAPIEN 3 transcatheter heart valve in the STS/ACC TVT Registry for the 2 years following device approval (i.e. from June 5, 2017 to June 4, 2019). All mitral transcatheter SAPIEN 3 Valve in Surgical Valve patients who have the procedure date in the period of June 5, 2017 to June 4, 2019 will be included in the analysis.
|
| Key Study Endpoints |
TVT-Captured Safety Endpoints (at discharge, 30 days and 12 months):
All-cause mortality
Heart failure rehospitalization*
Mitral valve reintervention
Device or procedure-related adverse events
Life threatening/major bleeding complications*
Stroke
TIA
Myocardial Infarction
New requirement of dialysis
New onset atrial fibrillation
Unplanned mitral valve surgery due to device/procedure failure or malfunction
Requirement for valve replacement
Unplanned cardiac surgery for any cause
Requirement/insertion of an implantable cardiac defibrillator
*endpoints not available at discharge
TVT-Captured Effectiveness Endpoints (30 days and 12 months):
6-minute walking distance
KCCQ
Change in NYHA functional class
Mitral valve hemodynamics
CMS-Captured Safety Endpoints (year 2 to 5):
All-cause mortality
All Stroke
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
|
| Follow-up Visits and Length of Follow-up |
5 year post-implantation
|
