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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a prospective, one-armed, multi-center observational study. This study will include data from 25
consecutive patients from the participating clinical centers with acute nght ventricular failure from any cause requiring use of the CentnMag RVAS to sustain life Patients may be enrolled from two populations The first population will include any patient in need of an RVAD that is not participating in the Levitronix
pivotal study entitled, "Levitronix CentnMag VAS Failure-to-Wean from Cardiopulmonary Bypass Trial" The second population will include patients who have been enrolled in the Levitronix pivotal trial and subsequently enrolled into this post approval study Patients enrolled in the pivotal study will already have a CentnMag RVAS in place
Study Population Description
The study population includes patients implanted with the dentrimag device. The CentriMag RVAS is intended
to provide temporary circulatory support for up to 14 days for patients in cardiogenic shock due to right ventricular failure. It is intended for use in patients with a body surface area of 1.4 m2 or greater.
Sample Size
25 consecutive patients implanted with the device will be followed from device implant to device
removal, and 30 days post RVAD removal.
Data Collection
The primary endpint in patients who recover and do not go on to transplantation or
use of a long-term device includes survival to 30 days post-support or to hospital discharge, whichever is longer. In patients who do not recover and are bridged to transplant or a long-term system the primary endpoint is survival to induction of anesthesia for implantation of a long-term device or heart transplant.
Followup Visits and Length of Followup
Clinical endpoints will be recorded at baseline, 3 days post-implant, prior to explant, and 30
