Esmore Donald, Spratt Phillip, Larbalestier Robert, Tsui Steven, Fiane Arnt, Ruygrok Peter, Meyers Deborah, Woodard John
The Alfred Hospital, Melbourne, Australia.
Eur J Cardiothorac Surg. 2007 Nov;32(5):735-44. doi: 10.1016/j.ejcts.2007.07.028. Epub 2007 Sep 6.
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 VentrAssisttrade mark Clinical Development Plan.
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.
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.
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.
总结使用VentrAssist左心室辅助装置的首个国际临床试验的主要疗效和安全性结果，并提供VentrAssist商标临床开发计划的最新情况。
2004年至2006年期间，在澳大利亚、英国和挪威对VentrAssist用于桥接移植患者进行了首个前瞻性、单臂、多中心国际临床试验（CE标志试验）。主要结局指标是存活至移植或术后第154天符合移植条件。还描述了VentrAssist临床开发计划中其他临床试验的数量和状态。
在CE标志试验完成时，30名患者中有25名（83%）接受了移植或符合移植条件。没有出现意外的安全问题，也没有报告VentrAssist泵出现失控停机的情况。VentrAssist目前的临床开发计划包括七项临床试验：两项已完成，三项正在进行，两项准备启动。截至2007年1月30日，全球14个中心共有87名患者植入了VentrAssist，总暴露时间超过43患者年，最长植入持续时间为2.7年。
VentrAssist临床试验的疗效和安全性数据良好，并因此获得了欧洲针对该适应症的监管批准。值得注意的是，VentrAssist的存活成功率高于其他左心室辅助装置的报告成功率。VentrAssist的植入总数现已超过任何其他第三代离心装置。
