Post-Approval Studies (PAS) Database

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

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
Interim or Final Data Summary
Interim Results	Safety Results: Freedom from RA lead-related complications (n=1,580 leads) was 99.4% (95% CI: 99.0%, 99.7%) at 15 months follow-up. Freedom from RV lead-related complications (n=927 leads) was 99.1% (95% CI: 98.4%, 99.5%) at 15 months follow-up. There were 11 patients with cardiac tamponade and 0 patients with cardiac perforation events through the data cut-off date (December 31, 2024).
Actual Number of Patients Enrolled	1685
Actual Number of Sites Enrolled	199
Patient Follow-up Rate	N/A

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	08/09/2024	On Time
18 month report	02/11/2025	02/10/2025	On Time
2 year report	08/11/2025	08/07/2025	On Time
3 year report	08/11/2026
4 year report	08/11/2027
5 year report	08/11/2028
6 year report	08/11/2029
final report	08/11/2030

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background