US-based HeartWare International has started the HVAD Lateral Study, a US investigational device exemption (IDE) clinical trial of advanced heart failure patients implanted through a less invasive thoracotomy technique.
The company said the first patient was treated in the trial, in which the HeartWare Ventricular Assist System, featuring HVAD Pump is implanted through a thoracotomy procedure in patients with end-stage heart failure who are awaiting a heart transplant.
The trial was designed to examine clinical outcomes of the thoracotomy technique.
Existing ventricular assist systems are only approved by US Food and Drug Administration for use with implantation through median sternotomy, a common surgical approach in cardiac surgery, which uses a vertical incision through the centre of the patient’s chest.
Co-principal investigator for the study Dr 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.”
Conducted at 30 US hospitals, the multi-centre and single-arm HVAD Lateral clinical trial will enrol 120 patients with end-stage heart failure who have not responded to standard medical management and who are eligible for cardiac transplantation.
Primary survival endpoint in the trial will be measured at six months post-implant and compared to a performance goal.
HeartWare president Doug Godshall said: “We have observed a marked increase in thoracotomy interest in the US and internationally, with more than 20% of global HVAD implants in the past year performed via this less-invasive method.
“We are encouraged that physicians are able to take advantage of the versatility of the HVAD Pump and look forward to confirming the potential benefits of the thoracotomy implant technique previously published through single-centre studies in the US and Europe.”