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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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OSB Lead-New Enrollment SAPIEN XT Pulmonic PAS


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General
Study Status Progress Adequate
Application Number P130009 S037/ PAS002
Date Current Protocol Accepted 04/03/2017
Study Name OSB Lead-New Enrollment SAPIEN XT Pulmonic PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To evaluate longer-term safety and effectiveness of the SAPIEN XT Transcatheter Heart Valve (THV) in the pulmonic position for the intended patient population (especially pediatric) when used as indicated with all valve sizes (SAPIEN XT THV 23, 26, 29 mm). Single-arm, prospective, multicenter post-approval study using a performance goal based on the original COMPASSION trial.

Study Population Description Pediatric and adult patients with a dysfunctional, non- compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention and:

• pulmonary regurgitation = moderate and/or

• mean RVOT gradient = 35 mmHg.

Sample Size A total of 191 patients will be enrolled at up to 20 sites in the US.

Data Collection Primary:

Freedom from device- or procedure-related death or reintervention at 1 year

Secondary:

Improved valve hemodynamics at 30 days, 1 year, 2 years and annually through 5 years as demonstrated via transthoracic echocardiogram (TTE):

a) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions

b) Decrease in RVOT mean gradient to less than 30mmHg for stenotic lesions

c) Improvement in both a) and b) above for mixed lesions.



Improvement of = 1 NYHA functional class from baseline for patients with NYHA functional class = 2 at baseline.

Recurrent pulmonary stenosis, defined as RVOT peak gradient greater than or equal to 36 mmHg at 30 days, 1 year, 2 years and annually through 5 years as demonstrated via TTE for patients with stenosis at baseline (RVOT peak gradient = 36 mmHg at baseline).

Device Success, defined as a composite of:

a) Deployment of the valve to the target area, and

b) Removal of the delivery catheter out of the body, and

c) Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.



Safety:

MACCE at 30 days and 1 year, defined as a composite of death, myocardial infarction, reintervention, vascular injury resulting in the need for an unplanned vascular intervention, stroke and pulmonary embolism

Follow-up Visits and Length of Follow-up 5 years


OSB Lead-New Enrollment SAPIEN XT Pulmonic PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/29/2016 08/25/2016 On Time
one year report 02/28/2017 02/28/2017 On Time
18 month report 08/29/2017 08/29/2017 On Time
two year report 02/28/2018    
three year report 02/28/2019    
five year report 02/27/2021    
Final Report 06/27/2025    


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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