VentrAssist™ left ventricular assist device:: Clinical trial results and Clinical Development Plan update

Objectives: To summarise the primary efficacy and safety results from the first international clinical trial with the VentrAssist (TM) left ventricular assist device and to provide an update on the VentrAssist (TM) Clinical Development Plan. Methods: The first prospective, single-arm, multicentre international clinical trial with the VentrAssist (TM) in bridge-to-transplant patients (CE Mark trial) was conducted in Australia, UK and Norway between 2004 and 2006. The primary outcome measure was survival until transplant or being transplant-eligible at postoperative day 154. The number and status of other clinical trials in the VentrAssist (TM) Clinical Development Plan are also described. Results: At the completion of the CE. Mark trial, 25 of the 30 patients (83%) were transplanted or transplant-eligible. There were no unexpected safety issues and no reported uncontrolled stops of the VentrAssist (TM) pump. The Clinical Development Plan for the VentrAssist (TM) currently comprises seven clinical trials: two are completed, three are ongoing and two are ready for initiation. As of January 30th, 2007, a total of 87 patients have been implanted with the VentrAssist (TM) at 14 centres worldwide, yielding a total exposure time of more than 43 patient-years and a maximum implant duration of 2.7 years. Conclusions: The efficacy and safety data from a clinical trial of the VentrAssist (TM) were favourable and resulted in gaining European regulatory approval for this indication. Notably, the survival success rate for the VentrAssist (TM) was higher than that reported for other left ventricular assist devices. The overall number of implants with the VentrAssist (TM) has now surpassed that of any other third-generation centrifugal device. (C) 2007 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.