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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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MADIT-CRT ACC NCDR


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General
Study Status Progress Adequate
Application Number P010012 S230/ PAS001
Date Current Protocol Accepted 01/18/2013
Study Name MADIT-CRT ACC NCDR
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Patients in the NCDR ICD Registry will be identified, who, at the time of

device implant were diagnosed with one of the following:

 NYHA functional class II with non-ischemic or ischemic cardiomyopathy

OR

 who are NYHA functional class I with ischemic cardiomyopathy



AND

 Have left ventricular dysfunction (EF ≤30%), prolonged intraventricular conduction (QRS ≥ 130 ms), and with a LBBB



These Registry patients will be further split into the following patient cohorts for the purposes of analysis.

CRT-D group: Patients implanted with a Boston Scientific CRT-D device after the MADIT-CRT indication approval date.

ICD group: Patients implanted with a Boston Scientific ICD; either, (a) after the MADIT-CRT indication approval date, or, (b) before the MADIT CRT indication approval date.

Sample Size A minimum of 1300 patients who meet the specified criteria; have

been implanted with a Boston Scientific CRT-D device followed for a minimum of 5 years.

A minimum of 1300 patients who meet the specified criteria; have been implanted with a Boston Scientific ICD device followed for a minimum of 5 years.

A minimum of 500 Class I patients who meet the specified criteria, including a minimum of 225 who have been implanted with a with a Boston Scientific CRT-D device, have been identified and followed for a minimum of 5 years.

Data Collection The primary endpoint for the study is to evaluate the ¿real-world¿ effect of

CRT-D, compared to ICD, on the time-to-all-cause mortality over a period of 5 years.

Follow-up Visits and Length of Follow-up 5-years post-implant.

Progress reports will be generated every 12 months and will include:

demographics, mortality, and procedural related adverse events.

General
Study Status Completed
Application Number P010012 S230/ PAS002
Date Current Protocol Accepted 09/27/2011
Study Name 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




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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