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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 Completed
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.
Interim or Final Data Summary
Actual Number of Patients Enrolled 109
Actual Number of Sites Enrolled 13
Patient Follow-up Rate One hundred and ninety-eight (198) leads among one hundred (100) subjects have completed either the 3-month visit or 91 days of follow-up. One hundred and one (101) subjects have completed the 3-month follow-up visit.
Final Safety Findings The lead-related complication-free rate from lead implant to 3 months for all leads was 98.5%, with a lower confidence limit of 95.4%.
Final Effect Findings As of the date of the report snapshot, 98.9% of leads (184 of 186) have reported a pacing capture threshold less than or equal to 2V with a 0.4ms pulse width.
Study Strengths & Weaknesses The safety endpoint through 3 months of follow-up was met. All effectiveness endpoints at 3 months of follow-up were met. The data confirms the safety and effectiveness of the INGEVITY+ lead.
Recommendations for Labeling Changes no


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


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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