Post-Approval Studies (PAS) Database

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

General
Study Status	Completed
Application Number / Requirement Number	P070008 S079/ 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
Clinical Trial Number(s)	NCT02290028
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 yrs < 22 yrs, Adult: At least 22 yrs
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
Actual Number of Patients Enrolled	2872
Actual Number of Sites Enrolled	N/A - RWE
Patient Follow-up Rate	N/A - RWE
Final Safety Findings	Primary safety objective of complication-free rate (CFR) greater than 92.5% at 5 years post-implant for Sentus LV leads was met. 84 complications noted in 2920 Sentus leads. Lower bound of the two-sided 95% confidence interval of CFR was 92.72%.
Final Effect Findings	N/A
Study Strengths & Weaknesses	This study’s use of real-world data captures a large representative assessment of device performance. While data granularity is limited, the study confirms there are no significant safety concerns with the device’s long term performance.
Recommendations for Labeling Changes	Labeling changes should include the study design, results, and strengths and weaknesses of the PAS.

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

Reporting Schedule	Report Date Due	FDA Receipt Date	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	11/02/2022	On Time
6 year report	11/04/2023	10/31/2023	On Time
final report	11/04/2024	10/30/2024	On Time

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background