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

^a The Alfred Hospital, Melbourne, Australia
^b St Vincent's Hospital, Sydney, Australia
^c Royal Perth Hospital, Perth, Australia
^d Papworth Hospital, Cambridge, United Kingdom
^e Rikshospitalet, Oslo, Norway
^f Auckland City Hospital, Auckland, New Zealand
^g Prince Charles Hospital, Brisbane, Australia
^h Ventracor Limited, Sydney, Australia

Received 13 March 2007; received in revised form 16 July 2007; accepted 17 July 2007.

^_* Corresponding author. Address: Ventracor Limited, 126 Greville Street, Chatswood, NSW 2067, Australia. Tel.: +61 2 9406 3102; fax: +61 2 9406 3111. (Email: john.woodard{at}ventracor.com).

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.

Key Words: Assisted circulation • Heart-assist devices • Heart transplantation • Heart failure, congestive • VentrAssist^TM

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