FDA clears HeartWare device for destination therapy trial
HeartWare International, a developer of miniaturized circulatory support technologies to treat advanced heart failure, has received conditional approval from the FDA to begin enrollment in an investigational device exemption (IDE) destination therapy clinical study for the HeartWare ventricular assist system.
Designed to enroll up to 450 patients at 50 U.S. hospitals, the non-inferiority ENDURANCE study is a randomized, controlled, unblinded, multicenter clinical trial to evaluate the use of the HeartWare ventricular assist system as a destination therapy in advanced heart failure patients. The study population will be selected from patients with end-stage heart failure who have not responded to standard medical management and who are ineligible for cardiac transplantation, according to the Framingham, Mass.-based HeartWare.
Patients in the study will be randomly selected to receive either the HeartWare ventricular assist system or, as part of a control group, they will be implanted with any alternative left ventricular assist device (LVAD) approved by the FDA for destination therapy, in a 2:1 ratio, the company said. Each patient 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 primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.
Designed to enroll up to 450 patients at 50 U.S. hospitals, the non-inferiority ENDURANCE study is a randomized, controlled, unblinded, multicenter clinical trial to evaluate the use of the HeartWare ventricular assist system as a destination therapy in advanced heart failure patients. The study population will be selected from patients with end-stage heart failure who have not responded to standard medical management and who are ineligible for cardiac transplantation, according to the Framingham, Mass.-based HeartWare.
Patients in the study will be randomly selected to receive either the HeartWare ventricular assist system or, as part of a control group, they will be implanted with any alternative left ventricular assist device (LVAD) approved by the FDA for destination therapy, in a 2:1 ratio, the company said. Each patient 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 primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.