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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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Study Status Completed
Application Number P060040 / PAS001
Date Current Protocol Accepted 04/21/2008
Study Name INTERMACS Registry
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 The proposed study is a prospective non-randomized observational study, with subjects obtained from the INTERMACS Registry, which included at least 84 sites with IRB approval as of December 31, 2007. The sponsor proposes to use the first 169 patients implanted with HeartMate II and the first 169 controls. If less than 169 control patients have entered the study by the time that 169 HeartMate patients have entered the study, consecutive controls will be chosen retrospectively.
Study Population Description All patients who are identified pre-implant in the INTERMACS database as "Bridge to Transplant (patient currently listed for transplant)" or "Possible Bridge to Transplant - Likely to be eligible" will be enrolled in the post market study. Patients implanted with the Heartmate II will comprise the study group and patients implanted with any other LVAD will comprise a concurrent comparator group. In addition, all other patients implanted with a HeartMate II during the post market study, who are not part of an IDE, and not "Bridge to Transplant (patient currently listed for transplant)" nor "Possible Bridge to Transplant - Likely to be eligible" will be analyzed as a separate group to help assess how the device is used in the community.
Sample Size 169 HeartMate patients and 169 controls from the INTERMACS Registry
Data Collection Endpoints include: 1) procedural success, 2) incidence of adverse events. Bleeding adverse events will include information on date and site of bleeding, anticoagulation use, and amount of blood transfusion, 3) Device malfunctions and failures, 4) Quality of Life as measured by EuroQOL (at 3 and 6 months), 4) Neurocognitive function (Trailmaking B), assessed in a subset of sites, detailed in a separate protocol, and 5) One year post explant survival.
Follow-up Visits and Length of Follow-up All subjects and controls will be assessed at one week, one month, 3 months, 6 months, and one year post explant. Patients will be followed until one year post explant.
Interim or Final Data Summary
Interim Safety Information Most adverse events occur with similar frequencies in the HeartMate II and the control groups. Hypertension is more frequent in the control group.
Actual Number of Patients Enrolled 338
Actual Number of Sites Enrolled 77
Patient Follow-up Rate 99
Final Safety Findings The most common adverse events overall were bleeding, infection, cardiac arrhythmia, and respiratory failure. Compared to the Comparison group, HMII patients had significantly lower risk for adverse events including device malfunctions. The most common type of device malfunction was ¿external control system failure, 21 cases reported.
Final Effect Findings Success was defined as LVAS support for at least 180 days or to transplant, or to explant due to myocardial recovery and survival for at least 60 days post explant. Ninety-percent (90%) of the HMII patients achieved success compared to 79% of the Comparison patients (Fishers exact P=0.0064).
Study Strengths & Weaknesses Strengths: Follow-up rate was very high (99%); all subjects were prospectively followed; a concurrent control group was available for comparison; all data was collected and evaluated through a registry that utilized standardized methods for data collection and evaluation.

Weakness: Potential confounding variables were not controlled for in comparing subjects with controls ¿ however, baseline data was similar in the two groups.

Recommendations for Labeling Changes Labeling changes should be accomplished in accordance with the findings of the PAS.

INTERMACS Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/20/2008 10/15/2008 On Time
1 year report 04/21/2009 04/20/2009 On Time
18 month report 10/20/2009 10/20/2009 On Time
2 year report 04/21/2010 04/13/2010 On Time
Final Report 04/21/2011 04/15/2011 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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