TY - JOUR
T1 - VentrAssist™ left ventricular assist device
T2 - clinical trial results and Clinical Development Plan update
AU - Esmore, Donald
AU - Spratt, Phillip
AU - Larbalestier, Robert
AU - Tsui, Steven
AU - Fiane, Arnt
AU - Ruygrok, Peter
AU - Meyers, Deborah
AU - Woodard, John
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2007/11
Y1 - 2007/11
N2 - 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.
AB - 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.
KW - Assisted circulation
KW - Heart failure, congestive
KW - Heart transplantation
KW - Heart-assist devices
KW - VentrAssist™
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U2 - 10.1016/j.ejcts.2007.07.028
DO - 10.1016/j.ejcts.2007.07.028
M3 - Article
C2 - 17825576
AN - SCOPUS:34848923730
VL - 32
SP - 735
EP - 744
JO - European Journal of Cardio-thoracic Surgery
JF - European Journal of Cardio-thoracic Surgery
SN - 1010-7940
IS - 5
ER -