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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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DirectSense RF Sub-study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P150005 S049/ PAS001
Date Original Protocol Accepted 05/29/2020
Date Current Protocol Accepted 03/25/2024
Study Name DirectSense RF Sub-study
Device Name IntellaNav MiFi Open-Irrigated Ablation Catheter
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of the DirectSense RF sub-study is to collect data to support the use and labeling for the new DIRECTSENSE™ RF feature used with IntellaNav MiFi Open Irrigated Ablation Catheters to treat Paroxysmal Atrial Fibrillation.
Study Population The sub-study will enroll patients from the INTERRUPT AF PAS who are treated using the DirectSense RF feature during the cardiac ablation procedure.
Sample Size 156 subjects treated with DirectSense RF from INTERRUPT AF PAS will be included in the DirectSense RF sub-study.
Key Study Endpoints Safety: The primary safety endpoint is defined as the safety event-free rate at 12 months post-procedure.
Effectiveness: The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure
Follow-up Visits and Length of Follow-up 3 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 350
Actual Number of Sites Enrolled 25
Patient Follow-up Rate 45 withdrawals
Final Safety Findings 215 of the 350 enrolled subjects have completed their 12 months visit and 37 have completed their 36 months visit. A total of 240 events have been reported overall, of which 75 are new since the 36-month report. There have been no unanticipated events. 18 complications were EP related, including 5 pericardial effusions. 2 deaths have been reported - these were from the 36-month report. No new concerns at this time.
Final Effect Findings There have been 18 device deficiencies overall, of which only 2 are new since the 36-month report.


DirectSense RF Sub-study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/16/2020 10/23/2020 Overdue/Received
18 month report 11/01/2021 10/19/2021 On Time
30 month report 11/01/2022 10/26/2022 On Time
42 month report 11/01/2023 10/27/2023 On Time
54 month report 11/01/2024    


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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