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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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Study Status Progress Adequate
Application Number P070008 S079/ PAS001
Date Current Protocol Accepted  
Study Name QP ExCELS Sentus QP Ext CRT w/ Quad LV
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 Design Description 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 Description CRT-eligible Heart Failure patients
Sample Size Postmarket Sample Size Required: 979
Postmarket Sample Size Required including attrition = 1754
Data Collection 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 Safety Information A total of 104 complications were identified in 96 Sentus leads. Of these 104 complications, 70
were attributable to the Sentus lead.
Actual Number of Patients Enrolled 2845
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Study Strengths & Weaknesses The study is progressing as expected

QP ExCELS Sentus QP Ext CRT w/ Quad LV Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 11/02/2017 11/02/2017 On Time
1 year report 11/04/2018 11/02/2018 On Time
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    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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