f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

CONVERGE Post-Approval Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number /
Requirement Number
P200002 / PAS001
Date Original Protocol Accepted 04/28/2021
Date Current Protocol Accepted 10/13/2022
Study Name CONVERGE Post-Approval Study
Device Name EPi-Sense Guided Coagulation System
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 Objectives The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense and Epi-Sense ST Guided Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

The study is a prospective single arm study with safety and effectiveness compared to performance goals which are based upon published literature.
Study Population Patients at sites participating in Medtronic’s Cryoablation Registry, who are 18 years of age or older and are recommended for ablation with the Artic Front Cardiac Cryoablation Catheter System for treatment of persistent atrial fibrillation.

Sample Size 325 subjects will be enrolled. This sample size will have 90% power for the Primary effectiveness and 80% power for the primary safety endpoints
Key Study Endpoints The primary effectiveness endpoint is defined as freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-months post procedure follow-up visit
The Primary Safety Endpoint is the severe adverse event rate through 12-months post-procedure.
The primary safety endpoint for the study includes major adverse events (MAEs):
The incidence of MAEs through 30-days post Hybrid Convergent procedure
The incidence of MAEs related to Hybrid Convergent procedure
The incidence of MAEs related to Hybrid Convergent devices
Additional endpoints: Clinically significant pericardial effusion;
Device and procedure related serious adverse events through 12-months post-procedure;
Change in AF symptoms from baseline to 12-, 18-, 24-, and 36-months post-procedure;
Freedom from AF/AT/AFL >30 seconds duration absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-months post procedure follow-up visit. Evaluated based on the first 24 hours of the 7-days Holter monitoring and symptom-driven event monitoring;
Freedom from any AF/AFL/AT >30 seconds duration without a Class I/III AAD prescribed for AF following the 3-month blanking period through 12- 18-, 24- and 36- months post-procedure;
Freedom from any AF/AFL/AT >30 seconds duration with or without an AAD prescribed for AF following the 3-month blanking period through 12-, 18-, 24- and 36- months post -procedure;
Residual AF burden / reduction in overall AF burden at 12-, 18-, 24- and 36-months post procedure when compared to baseline; and
Change in AF-specific Quality of Life (QoL) score(s) at 12-, 18-, 24- and 36- months post-index procedure when compared to baseline score.

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



CONVERGE Post-Approval Study Reporting Schedule

Reporting 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 10/25/2022 On Time
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

-
-