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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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CONVERGE Post-Approval Study


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General
Study Status Progress Adequate
Application Number P200002 / PAS001
Date Current Protocol Accepted 01/10/2022
Study Name CONVERGE Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, multi-center, open-label, single-arm study to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated with the EPi-Sense Guided Coagulation System to treat symptomatic long-standing persistent atrial fibrillation in patients who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD).
Study Population Description Patients diagnosed with long-standing persistent AF defined in accordance with the 2017 HRS/EHRA/ECAS/APHPRS/SOLAECE Expert Consensus Statement. Long-standing persistent is defined as continuous AF of greater than 12-months duration.

Sample Size The study will enroll up to 325 patients at 50 sites in the United States, United Kingdom, and European Union.
Data Collection The primary effectiveness endpoint will be compared to a performance goal (PG) of 50%.

The primary safety endpoint will be compared to a PG of 14%.

Follow-up Visits and Length of Follow-up All treated subjects will be followed for a total of 36-months.



CONVERGE Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/27/2021 10/20/2021 On Time
1 year report 04/28/2022 04/27/2022 On Time
18 month report 10/27/2022    
2 year report 04/28/2023    
3 year report 04/27/2024    
4 year report 04/27/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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