HeartWare International, a provider of less invasive, miniaturized circulatory support technologies in the treatment of advanced heart failure, has concluded the patient enrollment under its 'Advance' clinical trial.
HeartWare’s Advance clinical trial is an FDA approved IDE study designed to evaluate the HeartWare Ventricular Assist Device (VAD) System as a bridge to heart transplantation for patients with end-stage heart failure.
The primary endpoint of the trial is survival at 180-days, defined as alive on the originally implanted device or transplanted or explanted for 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.
With completion of the Advance enrollment, HeartWare has been seeking approval from the FDA to implant additional bridge-to-transplant patients under a Continued Access Protocol or ‘CAP’ in any US center that implanted a patient under the trial. To advance the clinical development of the HeartWare System, HeartWare has also submitted a protocol to the FDA for a Destination Therapy (DT) trial in the US.
Doug Godshall, president and CEO of HeartWare, said: “We witnessed a growing enthusiasm from investigators during this study, and we are grateful for their continued support. We also had an unexpected acceleration to the completion of the enrollment phase of the trial.
“During discussion with the FDA, we were asked to change the definition of ‘enrolled’ in our IDE protocol to include patients who were consented to enter the trial, as opposed to those who were consented and met all inclusion and none of the exclusion criteria. With two additional implants scheduled, this modification will result in 30 US clinical sites implanting a total of 140 patients, making Advance the largest bridge-to-transplant pivotal trial to date.”