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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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Destination Therapy-INTERMACS

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Study Status Completed
Application Number P060040 S005/ PAS001
Date Current Protocol Accepted 05/07/2010
Study Name Destination Therapy-INTERMACS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
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 registry of patients receiving the HeartMate II LVAS for the Destination Therapy indication. The purpose of a post-approval study for the HeartMate II as Destination Therapy is to assess whether the commercial use of the device produces results that are comparable to results observed in the HM II Destination Therapy clinical trial.
Study Population Description Study Populaton: The post-approval study is a prospective registry of patients receiving the HeartMate II LVAS for the Destination Therapy indication. The HeartMate II LVAS is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class 3B or 4 with endstage left ventricular failure who have received therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation.
Sample Size 247 patients, over 105 sites, utilizing the INTERMACS Registry
Data Collection The primary objective of the HeartMate II Destination Therapy Post-Approval Study is to assess two-year patient survival free of stroke or reoperation to replace the device following HeartMate II implantation for Destination Therapyin a commercial setting. The following secondary objectives will be evaluated: 1) Incidence of adverse events 2) Clinical reliability; percutaneous lead (malfunctions/failures), and 3) Quality of Life as measured by EuroQOL instrument.
Follow-up Visits and Length of Follow-up Post implant, patients will be assessed at 1 week, 1, 3, 6, 12, and 24 months.
Interim or Final Data Summary
Interim Safety Information No safety data is available for this study.
Actual Number of Patients Enrolled 247
Actual Number of Sites Enrolled 61
Patient Follow-up Rate 99.6%
Final Safety Findings Most frequent overall:

Bleeding (54%, 0.84 per patient year [ppy]) Infection (57%, 0.88 ppy)

Respiratory failure (27%, 0.23 ppy)

Most frequent <30 Days: Bleeding (38%, 7.19 ppy) Infection (24%, 4.23 ppy)

Respiratory failure (19%, 3.01 ppy)

Most frequent >30 Days Bleeding (36%, 0.50 ppy) Infection (52%, 0.70 ppy)

Cardiac Arrhythmia (24%, 0.23 ppy) Device Malfunction (17%, 0.13 ppy)

There were 9 reports of thrombus as reported by INTERMACS.

- Death n=1

- Exchange/explant n=9

- Support durations 0.2 - 16.9 months

QoL improved for both patient groups from pre-implant to 24 months.

Final Effect Findings Success rate including transplant/recovery pts HMI II ¿ 139 (56%) vs. IDE ¿ 58 (44%); p=0.0236

Success rate excluding transplant/recover pts

HMI II ¿ 54% vs. IDE 44%; p=0.0819

24-month survival for HM II ¿ 61.3%

Study Strengths & Weaknesses High follow-up rate, but concerns about possible unreported adverse events. Without a requirement for device explant studies, no further investigation into the location of the 9 thrombus events can be conducted.
Recommendations for Labeling Changes yes

Destination Therapy-INTERMACS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 07/21/2010 07/13/2010 On Time
New Report 6 months 10/11/2010 09/30/2010  
1 year report 01/20/2011 01/18/2011 On Time
18 month report 07/21/2011 07/11/2011 On Time
2 year report 01/20/2012 01/20/2012 Overdue
3 year report-FINAL REPORT 01/19/2013 01/23/2013 Overdue/Received

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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