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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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INGEVITY + LBBAP Post-Approval Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P150012 S158/ PAS001
Date Original Protocol Accepted 11/08/2024
Date Current Protocol Accepted  
Study Name INGEVITY + LBBAP Post-Approval Study
Device Name INGEVITY + Leads - Active Fixation
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Objectives Real World Evidence (RWE) methodology study to establish the safety and effectiveness of INGEVITY + pacing leads for use in left bundle branch area pacing (LBBAP) for patients with a pacing indication. The study is prospective single-arm, non-randomized, observational cohort using RWE methodologies from the Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) project.
Study Population The study will include all patients registered in Boston Scientific’s device tracking database with an INGEVITY+ lead implanted in the LBBA until at least 1,013 leads are followed to 5 years post-implant.
The study will also include patients with applicable data from the pre-market cohort.
Sample Size At least 1,013 implanted leads for chronic safety endpoint. At least 141 implanted leads are required for the acute safety endpoint. At least 137 lead measurements through 60 months are required to evaluated effectiveness endpoints.
Chronic safety endpoint drives overall sample size based on the following assumptions:
• Expected performance = 95%
• Performance goal = 92.5%
• One-sided significance level = 2.5%
• Power = 90%
Key Study Endpoints Safety Endpoints
Acute: The event-free rate from implant to 1 month.
Chronic: The event-free rate from 1 to 60 months.
Effectiveness Endpoints
Effectiveness 1: Percent of pacing capture threshold (PCT) responders defined as PCT less than or equal to 2 V.
Effectiveness 2: Percent of R-wave sensed amplitude responders defined as R-wave sensed amplitude greater than or equal to 5mV.
Follow-up Visits and Length of Follow-up Visits: N/A
Length of F/U: Patients will be followed through at least 5 years following the end of enrollment.


INGEVITY + LBBAP Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/16/2025    
2 year report 09/16/2026    
3 year report 09/16/2027    
4 year report 09/15/2028    


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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