Medical device company CardioKinetix has enrolled the first patient in a US pivotal trial of its minimally invasive ventricular partitioning device, designed to treat patients with heart failure caused by damage to the muscle following a heart attack.
By inserting a small catheter in the femoral artery, the Parachute ventricular partitioning device is deployed into the left ventricle to partition the damaged muscle, separating the non-functional heart segment from the healthy, functioning segment.
The implant will also decrease the overall volume of the left ventricle and restore its geometry and function, according to the company.
The multi-centre, randomised trial, named PARACHUTE IV, will enrol 500 patients to compare the safety and efficacy of the PARACHUTE implant with optimal medical therapy.
All-cause mortality and hospitalisation for worsening heart failure are the event-driven primary endpoints of the trial, while functional outcomes, quality of life and hemodynamic measures by echocardiography are the other key endpoints.
Interventional Cardiovascular Center, Research and Innovation Center at the Harrington Heart & Vascular Institute director and trial co-principal investigator Dr Marco Costa said many patients who have had a heart attack experience an extremely poor quality of life due to the debilitating symptoms of heart failure including shortness of breath, fatigue, lack of appetite, impaired thinking and increased heart rate.
"I am thrilled to be pioneering this exciting therapy in the United States, where there is a significant need for better treatments for this heart failure patient population," Costa said.
The Ohio State University Medical Center cardiovascular medicine division director and trial co-principal investigator Dr William Abraham said three-year data on the initial patients treated with the device were presented in October 2012.
"These strong and encouraging results provide confidence to initiate a landmark randomised, pivotal trial where a positive outcome will establish this technology as a primary therapy option for the treatment of ischemic heart failure patients," Abraham said.