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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) 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 EnrollMitraClip Analysis Cohort (MAC)


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General
Application Number P100009 / PAS002
Current Plan Approved 04/05/2016
Study Name OSB Lead-New EnrollMitraClip Analysis Cohort (MAC)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description A prospective cohort study, a subset of patients entered into the MitraClip TVT-Registry who fulfill the enrollment criteria and from sites/centers of excellence and experienced with performing and collecting 6MWT data and KCCQ data (i.e. sites/centers with at least 75% completion rate in terms of collecting both 6MWT and KCCQ data) will be included in MAC.



This is a new-enrollment study.

Study Population Description A subset of approximately 460 patients entered into the MitraClip TVT-Registry who fulfill the following criteria in MAC:

Significant symptomatic MR (? 3+) due to primary abnormality of the mitral apparatus, otherwise known as Degenerative Mitral Regurgitation (DMR).

Prohibitive risk for mitral valve surgery (MV) as determined by a heart team, which includes a cardiologist experienced in MV disease and a cardiac surgeon experienced in MV surgery, and existing comorbidities that would not preclude the expected benefit from reduction of the MR.

Perform the 6MWT at baseline or unable to perform the 6MWT due to cardiac reasons.



No comparator group.

Sample Size Assuming 10% withdrawal at 12 months, a sample size of 460

patients from the Prohibitive Risk DMR Patient Registry (PAS 1

Device Registry) is expected to provide 420 evaluable patients (not

lost-to-follow-up or discontinued) at 12 months post procedure.

Assumptions: The reported death rate at 30 days was 6.3% in the Prohibitive Risk DMR Cohort (Lim et al 2013); the all-cause mortality rate at 30 days was assumed to be 6.5%. The device- related complication rate was assumed to be ~6% at 12 months.

Because a majority of device-related complications are expected to occur within 30 days of the MitraClip procedure, the rate at 30

days was also assumed to be ~6%. Two thousand (2,000) simulations were performed to calculate sample size and power for the primary safety endpoint. A sample size of 420 evaluable patients provides >95% power to reject the null hypothesis at the

5% significance level.

Two thousand (2,000) simulations were performed to calculate sample size and power for the primary effectiveness endpoint. Assuming 37% attrition (25% death, 10% withdrawal, and 2% missing data) at 12 months, a sample size of 420 evaluable patients provides >95% power to reject the null hypothesis at the 5% significance level.

There will be a minimum of 15 sites and a maximum of 40 sites, with no more than 10% of patients (up to 46) from each site. Sites selected for participation in this study will be centers of excellence and experienced with performing and collecting 6MWT data and KCCQ data.
Data Collection Main safety endpoints:

A composite of death and device-related complications at 30 days

post-procedure. The device-related complications include single leaflet device attachment (SLDA), device embolization, device thrombosis, and other device-related events (e.g., endocarditis, MV stenosis), which result in MV re-intervention, unplanned other cardiac surgery, or unplanned vascular surgery or intervention through 30 days post-procedure.

Secondary safety endpoints:

All-cause mortality at 12 months, and device-related complications at 12 months.

Main effectiveness endpoints:

The change in 6MWT distance at 12 months over baseline.

Secondary effectiveness endpoints:

¿ MR severity at 12 months

¿ Change in LVEDV at 12 months over baseline

¿ Change in LVIDd at 12 months over baseline

¿ Change in KCCQ QoL at 12 months over baseline

NYHA Functional Class at 12 Months

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

Active follow-up of patients will be performed through 12 months


OSB Lead-New EnrollMitraClip Analysis Cohort (MAC) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report and 12 month report 07/28/2014 01/16/2015 Overdue/Received
18 month report 04/24/2015 04/30/2015 Overdue/Received
two year report 10/24/2015 10/22/2015 On Time
30 month report 04/24/2016 04/21/2016 On Time
three year report 10/24/2016    
Final Report 07/31/2017    


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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