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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) 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 ACC NCDR


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General
Application Number P010012 S230/ PAS001
Current Plan Approved 01/18/2013
Study Name OSB Lead-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.



OSB Lead-MADIT-CRT ACC NCDR Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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 09/15/2012 09/17/2012 Overdue/Received
three year report 01/31/2014 01/27/2014 On Time
four year report 01/31/2015 01/30/2015 On Time
five year report 01/31/2016 01/27/2016 On Time
six year report 01/31/2017    


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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