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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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UltiPace Lead RWE Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P960013 S122/ PAS001
Date Original Protocol Accepted 05/11/2023
Date Current Protocol Accepted  
Study Name UltiPace Lead RWE Study
Device Name Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of this post-approval study is to evaluate the long-term safety of the Abbott UltiPace lead. The study uses real world evidence data methods to link and evaluate multiple datasets.
Study Population All eligible patients who receive an Abbott IPG and UltiPace RA lead or RV lead (model LPA1231) for the first 12 months following UltiPace approval. . Patient inclusion will be further be restricted to those with Medicare Parts A & B coverage and not Part C (HMO) coverage at the time of implant to ensure data capture in Medicare FFS claims.
Sample Size Estimated at 7,500 RA leads and 7,500 RV leads. Minimum sample sizes of 645 RA leads and 645 RV leads are needed to provide 80% power to reject the null hypotheses.
Key Study Endpoints Primary Endpoints
• Freedom from UltiPace right atrial (RA) lead-related complications through 5 years of follow-up.
• Freedom from UltiPace right ventricular (RV) lead-related complications through 5 years of follow-up.
Secondary Endpoint
• Rate of cardiac tamponade or cardiac perforation events
Follow-up Visits and Length of Follow-up 5 years


UltiPace Lead RWE Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/11/2023 11/09/2023 On Time
1 year report 08/11/2024    
18 month report 11/11/2024    
2 year report 06/11/2025    
3 year report 06/11/2026    


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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