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™ left ventricular assist device and to provide an update on the VentrAssist™ Clinical Development Plan. Methods: The first prospective, single-arm, multicentre international clinical trial with the VentrAssist™ 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™ 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™ pump. The Clinical Development Plan for the VentrAssist™ 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™ 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™ were favourable and resulted in gaining European regulatory approval for this indication. Notably, the survival success rate for the VentrAssist™ was higher than that reported for other left ventricular assist devices. The overall number of implants with the VentrAssist™ has now surpassed that of any other third-generation centrifugal device.