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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SE Persistent AF (PsAF) PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P130026 S070/ PAS001
Date Original Protocol Accepted 08/17/2022
Date Current Protocol Accepted  
Study Name SE Persistent AF (PsAF) PAS
Device Name TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The proposed study is a prospective, non-randomized, single arm, multi-center, observation PAS study
Study Population 200 Persistent Atrial Fibrillation subjects
Sample Size 200
Key Study Endpoints The acute primary safety endpoint is the rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure utilizing the study catheter.
The secondary, long-term safety endpoint will be the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months.
The primary effectiveness endpoint will be the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months.
The secondary effectiveness endpoint will be the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months
Follow-up Visits and Length of Follow-up 36 months
Interim or Final Data Summary
Interim Results No summary of interim results available as of the most recent report.
Actual Number of Patients Enrolled 27
Actual Number of Sites Enrolled 8
Patient Follow-up Rate Insufficient time from subject enrollment to determine follow-up rate.
Study Strengths & Weaknesses Insufficient information available to determine strengths and weaknesses.


SE Persistent AF (PsAF) PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/05/2022 07/20/2022 Overdue/Received
1 year report 11/04/2022 11/03/2022 On Time
18 month report 05/05/2023 05/01/2023 On Time
2 year report 11/04/2023 11/01/2023 On Time
3 year report 11/03/2024    
4 year report 11/03/2025    


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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