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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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QP ExCELS Sentus QP Ext CRT w/Quad LV


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General
Study Status Ongoing
Application Number /
Requirement Number		 P050023 S105/ PAS001
Date Original Protocol Accepted 05/04/2017
Date Current Protocol Accepted 09/24/2019
Study Name QP ExCELS Sentus QP Ext CRT w/Quad LV
Device Name PACEMAKER ICD CRT NON IMPLANTED COMPONENTS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Confirm long-term safety of the Biotronik Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.
Study Population CRT-eligible Heart Failure patients
Sample Size Postmarket Sample Size Required: 979
Postmarket Sample Size Required including attrition = 1754
Key Study Endpoints Primary Endpoint: The purpose is to evaluate the long-term Sentus related complication-free rate through 5 years post-implant.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results A total of 121 complications identified. Of these, 82 were attributable to the Sentus lead (0.01 events/subject year).
Actual Number of Patients Enrolled 2869
Actual Number of Sites Enrolled N/A - RWE
Patient Follow-up Rate N/A - RWE


QP ExCELS Sentus QP Ext CRT w/Quad LV Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 year report 11/04/2019 10/31/2019 On Time
3 year report 11/04/2020 11/02/2020 On Time
4 year report 11/04/2021 11/03/2021 On Time
5 year report 11/04/2022 11/02/2022 On Time
6 year report 11/04/2023 10/31/2023 On Time
7 year report 11/04/2024    


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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