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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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QuickFlex u Model 1258T LV lead


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General
Study Status Completed
Application Number P030054 S130/ PAS001
Date Current Protocol Accepted 05/10/2010
Study Name QuickFlex u Model 1258T LV lead
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is designed to characterize the chronic performance of the St. Jude Medical QuickFlex® ì Model 1258T LV Lead.
Study Population Description Study Population: Patients with an approved indication, as per cardiovascular society guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). Indication: The device is indicated for the treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
Sample Size 1884 patients, 80 sites
Data Collection Complication free survival rate at 5 years for complications related to the RV lead or SJ4 connector is greater than 92.5%. The following complications will be included in this analysis: Cardiac perforation, Lead dislodgement that occurred greater than 30 days after implant, Lead insulation damage, Lead fracture, Lead/Port damage, Abnormal RV lead performance (abnormal lead defibrillation impedance, abnormal lead pacing impedance, elevated pacing thresholds, loss of capture, loss of defibrillation output, loss of sensing, oversensing, undersensing), Other unexpected complications that are considered related to the RV lead or SJ4 connector
Follow-up Visits and Length of Follow-up Patients will be followed every six months for 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled total of 1930 subjects were enrolled.
Actual Number of Sites Enrolled 76 study sites were enrolled.
Patient Follow-up Rate Follow-up rate at 5 years is 73.2%.
Final Safety Findings The LV lead-related complication free survival KM probability at 5 year is 94.5% with Lower Confidence Bound of 93.3% which is above the accepted boundary of 92.5%.

• 542 deaths were reported during the study. All deaths were adjudicated. 174 deaths were determined to be “Cardiac” while 190 deaths were “Non-Cardiac” and 178 deaths were “Unknown” (178). None of the deaths were reported as LV lead-related

• LV lead related complication rates:

o The complication rate of lead dislodgement or migration occurred after 30 days from implant is 2.2% which is lower than the expected rate of 3.5%.

o The complication rate of diaphragmatic or phrenic nerve simulation is 0.8% which is lower than the expected rate of 1.7%.

o The complication rate of loss of capture is 0.5% which is slightly higher than the expected rate of 0.4%.

o All other complications rates are less or equal to expected rate of 0.4%: abnormal LV lead performance (0.2%; lead fracture (0.1%); elevated pacing threshold (0.4%); lead insulation damage (0.1%; and all other unexpected LV related complications (0.2%)

o No complication of cardiac or coronary sinus perforation is reported.

Final Effect Findings The mean LV bipolar pacing capture threshold at 0.5ms pulse width was 2.04±1.60V with a 95% CI of 1.93V to 2.16V) (N=774) at 5 years which is within the expectation criteria of less than 3.5V.
Study Strengths & Weaknesses Strength: The QuickFlex u Model 1258T LV lead post approval study provided 5-year follow-up long term safety and effectiveness data. The primary study endpoints formally evaluated with hypothesis testing and all primary endpoints performance goals were met. Stratified female and male subgroup complication analysis was provided.

Weakness: The study weakness is the low sample size of 433 subjects at risk who completed 5- year follow-up, which does not meet the required sample size of 645 patients (500 minimum) for the LV lead related complications rate hypothesis testing.

Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post- approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.


QuickFlex u Model 1258T LV lead Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/08/2010 11/12/2010 Overdue/Received
one year report 05/10/2011 05/10/2011 On Time
18 month report 11/08/2011 11/09/2011 Overdue/Received
2 year report 05/09/2012 05/10/2012 Overdue/Received
30 month report 11/09/2012 11/13/2012 On Time
3 year report 05/09/2013 05/14/2013 Overdue/Received
42 month report 11/09/2013 11/12/2013 Overdue/Received
4 year report 05/09/2014 05/07/2014 On Time
54 month report 11/09/2014 11/24/2014 Overdue/Received
5 year report 05/09/2015 05/06/2015 On Time
66 month report 11/10/2015 11/10/2015 On Time
6 year report 05/09/2016 05/03/2016 On Time
78 month report 11/10/2016 11/10/2016 On Time
7 year report 05/09/2017 05/05/2017 On Time
final report 02/28/2018 02/26/2018 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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