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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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Heartmate II Bleeding Study

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Study Status Completed
Application Number P060040 S005/ PAS002
Date Current Protocol Accepted 05/07/2010
Study Name Heartmate II Bleeding Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective non-randomized observational study,with a primary objective of comparing high molecular weight von Willebrand factor multimer levels in nonpulsatile versus pulsatile left ventricular assist device recipients.
Study Population Description Study Population: 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.
Sample Size 10 nonpulsatile and 5 pulsatile (HeartMate XVE, Thoratec PVAD) for a total sample size of 15 patients
Data Collection Primary endpoint is to examine the change high molecular weight mutlimer von Willebrand factor from pre-operative levels in nonpulsatile and pulsatile device recipients to 7 days post procedure. Secondary endpoint examine HMW multimer vWF levels in patients who experience a bleeding event.
Follow-up Visits and Length of Follow-up All subjects will be assessed pre-procedure and 7days, 30 days and 6 months after device implantation (and/or preheart transplant and 7 days after heart transplant)
Interim or Final Data Summary
Interim Safety Information No safety data is available for this study.
Actual Number of Patients Enrolled 53 enrolled (36 included in analyses)
Actual Number of Sites Enrolled 2
Patient Follow-up Rate 18/52
Final Safety Findings All non-pulsatile VAD patients demonstrated significant reductions in vWF HMW multimer levels following VAD placement. By 30 days postimplantation 100% of non-pulsatile patients tested had reduction in their HMWM levels and AvWS. Therefore, there are additional factors related to AVWF beyond decreased HMVM.

1. Higher vWF Ag levels pre-implant were measured in the pulsatile recipients versus non-pulsatile and decreased slightly by 30 days post-implant in both.

2. VWF Ag levels were higher in the bleeders at all time points in non-pulsatile patients; and both bleeders and non-bleeders had lower 30 day and 6 month vWF Ag levels compared to pre-implant levels.

3. P-selectin levels did not change significantly from baseline following non-pulsatile pump implantation. P-selectin levels were significantly lower in non-bleeders prior to implant and at 30 days post-implantation.

4. D-dimer levels declined following surgery but remained elevated through the 12 months follow up measurements.

Study Strengths & Weaknesses Weaknesses: First, there were too few patients in the pulsatile group to power the study. Protocol deviations resulted in only 4 of the 10 pulsatile pumps being included. Of the 4 pulsatile pumps in the study, 3 patients recevied the HeartMate XVE and 1 received the Thoratec PVAD. Second, it was unclear if the loss of large mutlimers was inside or outside of the normal range of values for multimers seen in populations not included in the study.

Strengths: This study is hypothesis generating for future research to see if certain preoperative characteristics, such as high P-Selectin and high vWF levels, could help to identify patients who could be at an increased risk of bleeding postoperatively.

Recommendations for Labeling Changes None

Heartmate II Bleeding Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 07/21/2010 07/13/2010 On Time
final report 01/20/2011 01/20/2011 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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