HeartWare International has commenced HVAD Lateral Study, a US Investigational Device Exemption (IDE) clinical trial of advanced heart failure patients implanted through less invasive thoracotomy technique.
The company reported the first patient implant in the trial, in which the HeartWare Ventricular Assist System, featuring the HVAD Pump is implanted through a thoracotomy procedure in patients with end-stage heart failure who are awaiting a heart transplant.
The trial has been designed to study the clinical outcomes of the thoracotomy technique, according to HeartWare.
Loyola University Chicago Stritch School of Medicine Department of Thoracic and Cardiovascular Surgery professor and a co-principal investigator for the study Ed McGee said: "The thoracotomy implant technique holds considerable promise for making implantation easier for the surgeon and better tolerated by the patient.
"Implantation via thoracotomy allows for preservation of a sternotomy for a heart transplant, making that subsequent surgery less difficult for the bridge-to-transplant patient."
The HVAD Lateral study is a multi-center and single-arm clinical trial, which will enroll up to 120 patients at 30 US hospitals.
It will include patients with end-stage heart failure who have not responded to standard medical management and who are eligible for cardiac transplantation.
HeartWare noted that the primary survival endpoint will be measured at six months post-implant and compared to a performance goal.