HeartWare International has completed enrolling patients for its Endurance pivotal destination therapy clinical trial.
The controlled, multi-center, randomized, unblinded trial, which enrolled 450 patients, was designed to assess the use of the HeartWare ventricular assist system in patients with end-stage heart failure.
The primary endpoint of the trial includes survival at two years, defined as alive on the originally implanted device without a debilitating stroke, 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.
HeartWare president and chief executive officer Doug Godshall said, "Completing enrollment in this, the largest head-to-head ventricular assist device clinical trial to date, is a major achievement and we look forward to following this Destination Therapy patient population to primary endpoint over the next two years."
The company said HeartWare ventricular assist system is also under FDA review for a Bridge-to-Transplant indication.