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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+ Post Approval Study


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General
Study Status Progress Adequate
Application Number P150012 S083/ PAS001
Date Current Protocol Accepted 06/19/2020
Study Name INGEVITY+ Post Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.



The INGEVITY+ Clinical Study is a prospective, non-randomized, multi-center, post-market study.

Study Population Description This is a one-armed study where every subject is assigned to treatment, where treatment means implanted, or attempted implant of INGEVITY+ leads in the right atrium and ventricle.
Sample Size At least 105 subjects will be enrolled in the study to achieve 200 implanted or attempted leads.



The study will include approximately 20 sites in North America.

Data Collection Primary Safety Endpoint: Lead-related complication-free rate from implant through 3-months post-implant



Primary Effectiveness Endpoint: Pacing capture threshold at 3-months post-implant



Secondary Effectiveness Endpoint: Sensed amplitude and pacing impedance at 3-months post-implant

Follow-up Visits and Length of Follow-up The study duration for each subject is expected to be approximately 3 months. Subjects will be exited from the study after their 3 month visit.


INGEVITY+ Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/15/2020 05/22/2020 On Time
one year report 12/15/2020 12/15/2020 On Time
final report 06/15/2021 05/26/2021 On Time
two year report 12/15/2021    
three year report 12/15/2022    
four year report 12/15/2023    


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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