f Post-Approval Studies (PAS) Database
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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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STOP Persistent AF PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P100010 S098/ PAS001
Date Original Protocol Accepted 02/11/2021
Date Current Protocol Accepted  
Study Name STOP Persistent AF PAS
Device Name Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives This is a multi-center prospective new enrollment study utilizing a sponsor-led registry to estimate the 36-month freedom from Atrial Fibrillation recurrence in patients treated with the Arctic Front Cryoablation system for Persistent Atrial Fibrillation.
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 Up to 400 subjects will be enrolled in the study to obtain a minimum sample size of 355 patients treated. This sample size was determined to ensure sufficient statistical precision around the three-estimate of treatment effectiveness.
Key Study Endpoints The Primary Effectiveness endpoint will be freedom from recurrence of Atrial Fibrillation, Atrial Flutter, or Atrial Tachycardia at 36-months post treatment.
The Primary Safety Endpoint is the severe adverse event rate through 12-months post-procedure.
Additional endpoints will: characterize the cryoablation procedure in terms of acute procedural success, time in the cath lab, duration of procedure, duration of fluoroscopy, etc. The change in Quality of Life from baseline through 36 months will be estimated using the EuroQoL five-dimension questionnaire. All adverse events occurring through 36-months will also be summarized.
Follow-up Visits and Length of Follow-up Subjects will be followed for up to 36-months post-procedure.
Interim or Final Data Summary
Actual Number of Patients Enrolled 189
Actual Number of Sites Enrolled 13
Patient Follow-up Rate 75.3% 12-month completed


STOP Persistent AF PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/15/2021 05/17/2021 Overdue/Received
1 year report 11/15/2021 11/15/2021 On Time
18 month report 05/15/2022 05/13/2022 On Time
2 year report 11/15/2022 11/16/2022 Overdue/Received
30 month report 05/15/2023 05/11/2023 On Time
3 year report 11/15/2023 11/14/2023 On Time
4 year report 11/15/2024    


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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