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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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REVERSE NCDR ICD Registry Study


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General
Study Status Completed
Application Number P010031 S232/ PAS001
Date Current Protocol Accepted 06/29/2012
Study Name REVERSE NCDR ICD Registry Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective Cohort Study
Study Population Description Patients meeting the expanded CRT-D indication criteria are eligible to participate the analysis cohort.
Sample Size At least 1500 patients from US implanted with a Medtronic CRT-D device who meet the expanded indication criteria will be included in the analyses. A minimum of 500 patients with QRS duration will be included in the primary objective analysis.
Data Collection 5-year survival probability for patients implanted with a Medtronic CRT-D who meet the expanded indication criteria within percent precision.
Follow-up Visits and Length of Follow-up 5-years post-implant.

Reconciliation of mortality for patients identified through the NCDR® ICD Registry¿ will be completed monthly through 5-years post-implant.
Interim or Final Data Summary
Actual Number of Patients Enrolled 4639 patients
Actual Number of Sites Enrolled N/A: Patients are identified through the American College of Cardiology’s National Cardiovascular Data Registry for implantable cardioverter defibrillators (ACC-NCDR ICD registry).
Mortality through five years will be tracked for this cohort using the National Death Index.
Patient Follow-up Rate 5 years post-implant
Final Safety Findings Of the 4639 ICD Registry patients meeting expanded indication, a total of 799 deaths were identified. Of these deaths, 216 (27%) were female and 266 (33%) had narrow QRS (130 – 150 ms).
Based on this data, the sponsor reported a survival probability at 5 years of 77.2% (95% CI: 75.4% - 78.8%) as well as a significant difference in survival probability between male and female. Among female subjects 216 subjects died compared with 583 deaths for male subjects (hazard ratio: 0.73, 95% CI: 0.62-0.85, p < 0.0001). No significant difference in survival probability between the narrow QRS group and the group with wider QRS was also reported by the sponsor. Among narrow QRS subjects 266 subjects died compared with 533 deaths for the subjects with wider QRS (hazard ratio: 1.10, 95% CI: 0.95-1.28, p = 0.19).
Final Effect Findings Please see "safety" findings.
Study Strengths & Weaknesses The sponsor has collected sufficient data to address the primary objective of the study which was to estimate the 5-year survival probability for patients implanted with a Medtronic CRT-D meeting the expanded indication criteria within 3% precision. The Agency recommends that the sponsor update the labeling to incorporate the study findings.
Recommendations for Labeling Changes FDA recommends that the sponsor update the labeling for these devices to reflect the long-term data from the Post Approval Study.


REVERSE NCDR ICD Registry Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/03/2012 10/03/2012 On Time
one year report 04/04/2013 03/29/2013 On Time
18 month report 10/03/2013 10/02/2013 On Time
two year report 04/04/2014 03/20/2014 On Time
three year report 04/04/2015 03/30/2015 On Time
four year report 07/29/2016 08/01/2016 Overdue/Received
five year report 04/03/2017 03/31/2017 On Time
six year report 04/03/2018 03/29/2018 On Time
Final Report 06/03/2020 05/29/2020 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

Additional Resources

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