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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SAPIEN 3 Mitral Valve-in-Valve Comp Surv


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General
Study Status Progress Adequate
Application Number P140031 S028/ PAS002
Date Current Protocol Accepted  
Study Name SAPIEN 3 Mitral Valve-in-Valve Comp Surv
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 Design Description 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 Description 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.
Data Collection 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
Interim or Final Data Summary
Interim Safety Information At discharge, 8 all-cause deaths (3.6%) were reported. The Kaplan-Meier rate of all-cause death through 30 days was 6.7% (n=12 deaths). No adjudicated strokes or adjudicated mitral valve re-interventions were reported at discharge or 30-days.
Actual Number of Patients Enrolled 220 mitral valve-in-valve patients were enrolled in the TVT registry between June 5, 2017 through February 12, 2018.
Actual Number of Sites Enrolled A total of 113 sites were enrolled (*based on database closed at February 12, 2018)
Patient Follow-up Rate 80.3% at 30-days among patients with known visit status.

(*Patients with follow-up data (numerator) include those with follow-up completed or deaths prior to visit; patients with known visit status (denominator) include those with follow-up completed, with missed visit, death prior to visit, withdrawal and lost to follow-up.)
Study Strengths & Weaknesses Strength: This study uses real-world data collected through the national STS/ACC TVT Registry to assess the safety and effectiveness of SAPIEN 3 Transcatheter Heart Valve in patients with a failed surgical bioprosthetic mitral valve.

Limitation: Results summarized are interim data only. Data for effectiveness endpoints will be posted at a later date (December 2024).


SAPIEN 3 Mitral Valve-in-Valve Comp Surv Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/04/2017 12/05/2017 Overdue/Received
one year report 06/05/2018 06/04/2018 On Time
18 month report 12/04/2018    
two year report 06/05/2019    
three year report 06/04/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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