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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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OSB Lead-MADIT-CRT Registry

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Study Status Completed
Application Number P010012 S230/ PAS002
Date Current Protocol Accepted 09/27/2011
Study Name OSB Lead-MADIT-CRT Registry
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 394 patients
Actual Number of Sites Enrolled 49 centers
Patient Follow-up Rate 98.98% (390/394)
Final Safety Findings The rate of device system related adverse events (number of Events/100 Device Months) is slightly higher in the CRT-D compared to ICD (0.54 in CRT-D vs. 0.36 in ICD) in this PAS Registry that is expected and consistent to the findings in the IDE study. The Registry showed a higher rate of early ERI (elective replacement indicator) in CRT-D group (4.1%) compared to ICD only group (2.7%) with longer follow-up indicating rapid battery depletion secondary to increased amount of pacing needed over time for cardiac resynchronization. The incidence of device-related adverse events for CRT-D in the Registry is in the acceptable range.
Final Effect Findings The cohort of combined IDE and Registry for followed out through 5 years showed CRT-D reduced a

32% relative risk of all-cause mortality in LBBB subpopulation as compared to ICD (p=0.028). CRT-D

was also associated with significant reduction in the risk of a first heart failure event and recurrent heart failure events in both the LBBB subsets and all subjects in combined IDE and Registry.

Study Strengths & Weaknesses Strength: long-term follow-up (5 years)

Weakness: small sample size (394 patients) insufficient to test statistical significance in crossover analysis and efficacy analysis

Recommendations for Labeling Changes NO

OSB Lead-MADIT-CRT Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/17/2011 03/16/2011 On Time
one year report 09/16/2011 09/14/2011 On Time
18 month report 03/16/2012 03/15/2012 On Time
two year report 09/16/2012 09/17/2012 Overdue/Received
30 month report 03/16/2013 03/14/2013 On Time
three year report-final report 10/31/2013 10/30/2013 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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