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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Study Status Completed
Application Number P030054 S173/ PAS001
Date Current Protocol Accepted 03/02/2012
Study Name QUAD PAS
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 Prospective multi-center study
Study Population Description Patients can be approached in one of two ways for enrollment:

¿ Through patient participation in the Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study (IDE Study patients); or

¿ Through participating centers with newly implanted patients.

Sample Size 1,884 new patients will be enrolled to achieve an evaluable sample size of 1,036 patients. In addition, patients will be included for total sample size. 80 active centers enrolled in this study.
Data Collection Primary endpoints: to estimate:

¿ Freedom from system-related complications through 5 years.

¿ Freedom from system-related complications through 5 years.

¿ Mean of programmed LV lead pacing capture threshold across 10 pacing configurations at 5 years.

Secondary endpoints: To characterize the complication rate of the Quartet Model 1458 LV Lead and to perform a trend analysis of all complications.

Follow-up Visits and Length of Follow-up All patients will have a total duration of follow-up of 5 years from the

date of implant

Patients who have a successful system implant will be seen at 6

months (+ 45 days) after implant and every 6 months (+ 60 days)

thereafter until the patient reaches the 5 year visit.

Interim or Final Data Summary
Actual Number of Patients Enrolled 1,970
Actual Number of Sites Enrolled 71
Patient Follow-up Rate 796 completed at 5 year follow up
Final Safety Findings The freedom from complications rate is 89.6%, which exceeds the 80% primary endpoint 1.

There was no significant difference between the IDE rollover and newly enrolled subjects regarding freedom from system-related complications through 5 years. The freedom from lead complications rate is 95.9%, which exceeds the 92.5% primary endpoint 2. Primary lead complication is dislodgement. None of the deaths were related to the system.

Final Effect Findings Mean lead pacing capture threshold met endpoint 3.
Study Strengths & Weaknesses This is a prospective, multicenter study that provides long term data up to 5 years on the safety and effectiveness of the device. The study outcomes are positive. The follow up rate was a challenge.
Recommendations for Labeling Changes The labeling will be updated based on the 5 year safety and effectiveness results reported in the PAS final report.

QUAD PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 05/29/2012 05/29/2012 On Time
one year report 11/28/2012 12/03/2012 Overdue/Received
18 month report 05/29/2013 05/29/2013 On Time
unsolicited report 11/25/2013 11/25/2013 On Time
two year report 11/28/2013 11/26/2013 On Time
rqst to change reporting 02/28/2014 02/28/2014 On Time
30 month report 05/29/2014 05/23/2014 On Time
three year report 11/28/2014 12/08/2014 Overdue/Received
42 month report 05/29/2015 06/01/2015 Overdue/Received
four year report 11/28/2015 12/01/2015 Overdue/Received
54 month report 05/28/2016 06/01/2016 Overdue/Received
five year report 11/27/2016 11/28/2016 Overdue/Received
six year report 11/27/2017 11/22/2017 On Time
seven year report/final report 06/28/2019 06/28/2019 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

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