HeartWare International has completed patient enrolment in an Endurance pivotal destination therapy clinical study designed to evaluate the use of the HeartWare ventricular assist system in patients with end-stage heart failure.
The CE-marked HeartWare ventricular assist system comprises an HVAD pump and a small full-output circulatory support device designed to be implanted next to the heart, eliminating the need for abdominal surgery generally required to implant competing devices.
Endurance is a randomised, controlled, unblinded, multi-centre clinical trial that enrolled 450 patients with end-stage heart failure who have not responded to standard medical management and who are ineligible for cardiac transplantation.
The aim of the trial is to investigate the ability of the HeartWare ventricular assist system as a destination therapy in advanced heart failure patients.
In the study, patients were randomly selected to receive either the HeartWare ventricular assist system or, as part of a control group, any alternative left ventricular assist device (LVAD) in a 2:1 ratio.
Patients receiving the HeartWare ventricular assist system or control LVAD will be followed to the primary endpoint at two years, with a subsequent follow-up period extending to five years post implant.
The study's primary endpoint is survival at two years, while the secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalisation, assessment of neurocognitive function and patient quality of life.
HeartWare International president and chief executive officer Doug Godshall said: "With enrolment of the study complete, we are pleased to report that more than 2,000 end-stage heart failure patients globally have received the HeartWare ventricular assist system."
Currently, the ventricular assist device is under US clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy.
The company develops and manufactures miniaturised implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure.