HeartWare International has completed the enrollment of patients in its Endurance2 destination therapy clinical trial, which is designed to assess patients implanted with the firm’s Ventricular Assist System for long-term use as destination therapy in the US.
The data from the trial will serve as basis for a pre-market approval (PMA) application to get approval for the system as destination therapy.
HeartWare International president and CEO Doug Godshall said: "We are delighted to have completed enrollment in this important study and would like to thank the investigators, coordinators and entire heart team at each hospital site for participating in this trial and for focusing on improved patient management.
"This second phase of our destination therapy trial reflects HeartWare’s commitment to research and to the betterment of patient outcomes."
Endurance2, a supplemental cohort of the firm’s Endurance destination therapy trial, is a prospective, randomized, controlled, unblended and multi-center assessment of the stroke incidence in patients implanted with an HVAD Pump who receive optimal blood pressure management.
The trial has enrolled up to 465 patients at one of the 50 participating hospital centers in the US between October 2013 and August 2015.
The patients have been randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative left ventricular assist device (LVAD) approved by the FDA for destination therapy, in a 2:1 ratio.
According to the firm, the study’s primary endpoint is incidence of neurologic injury at 12 months on the originally implanted device and the endpoint will be tested for non-inferiority against the control device.