HeartWare International, a provider of less invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, has received FDA grant of conditional approval to begin enrollment in an investigational device exemption (IDE) destination therapy clinical study for the HeartWare Ventricular Assist System.
The non-inferiority randomized, controlled, unblinded, multi-center clinical trial, ‘Endurance’, is designed to enroll up to 450 patients at 50 US hospitals, to evaluate the use of the HeartWare Ventricular Assist System as a destination therapy in advanced heart failure patients.
In the study, the patients selected are expected to be with end stage heart failure who have not responded to standard medical management and who are ineligible for cardiac transplantation.
HeartWare said that the patients in the study are randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group they are expected to be implanted with any alternative LVAD approved by the FDA for destination therapy, in a 2:1 ratio.
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, hospitalisation, assessment of neuro-cognitive function and patient quality of life.
There are three minor open questions raised by the FDA which are the ‘conditions’ to approval. Patient enrollment for the Endurance study can commence immediately, subject to Institutional Review Board (IRB) approvals at trial centers.
Doug Godshall, president and chief executive officer of HeartWare, said: “Initiation of this destination therapy study is an important milestone toward our goal of expanding the universe of potential patients that could benefit from less invasive circulatory support systems.
“We have been gratified by the support received from all of the prestigious cardiac centers that have participated in our bridge-to-transplant trial and we believe that this study, the largest head-to-head VAD clinical trial to date, will be compelling for cardiologists, surgeons and end-stage heart failure patients.”