In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
247 patients, over 105 sites, utilizing the INTERMACS Registry
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.
Followup Visits and Length of Followup
Post implant, patients will be assessed at 1 week, 1, 3, 6, 12, and 24 months.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
Most frequent overall: Bleeding (54%, 0.84 per patient year [ppy]) Infection (57%, 0.88 ppy) Respiratory failure (27%,