VentrAssist™ left ventricular assist device:: Clinical trial results and Clinical Development Plan update
VentrAssist™ left ventricular assist device:: Clinical trial results and Clinical Development Plan update
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DOI：
10.1016/j.ejcts.2007.07.028
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发表时间：
2007-11-01
影响因子：
3.4
通讯作者：
Woodard, John
中科院分区：
文献类型：
--
作者：
Esmore, Donald;Spratt, Phillip;Woodard, John
目的：总结首次国际临床试验中使用THERASAssist（TM）左心室辅助装置的主要有效性和安全性结果，并提供THERASAssist（TM）临床开发计划的更新。研究方法：2004年至2006年期间，在澳大利亚、英国和挪威进行了第一次前瞻性、单臂、多中心国际临床试验，试验中使用了THEMASS（TM），用于桥移植患者（CE标志试验）。主要结局指标为移植前存活率或术后154天符合移植条件。还描述了EASYAssist（TM）临床开发计划中其他临床试验的数量和状态。结果：CE完成时。Mark试验中，30例患者中有25例（83%）接受了移植或符合移植条件。没有出现意外的安全问题，也没有报告称，EQUIPAssist（TM）泵出现不受控制的停止。临床开发计划目前包括七项临床试验：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名患者植入了植入辅助器（TM），总暴露时间超过43患者-年，最长植入持续时间为2.7年。结论：从一项临床试验的疗效和安全性数据的辅助（TM）是有利的，并导致获得欧洲监管机构批准的这一适应症。值得注意的是，心脏辅助装置（TM）的生存成功率高于其他左心室辅助装置。植入物的总数量与辅助（TM）现在已经超过了任何其他第三代离心装置。(C)2007年欧洲胸外科协会。Elsevier B. V.出版，保留所有权利。
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.