CardioKinetix has completed enrolling the first patient in PARACHUTE IV trial of its Parachute ventricular partitioning device for treating heart failure patients.
The minimally invasive device is deployed into the left ventricle to partition the damaged muscle, separating the non-functional heart segment from the healthy functional segment, as well as to decrease the overall volume of the left ventricle and restore its geometry and function.
The multi-center, randomized trial will enroll 500 patients to compare the safety and efficacy of PARACHUTE implant with optimal medical therapy.
All-cause mortality and hospitalization 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 Marco Costa said, "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."
The Ohio State University Medical Center cardiovascular medicine division director and trial co-principal investigator William Abraham said three-year data on the initial patients treated with Parachute device were presented in October 2012.
"These strong and encouraging results provide confidence to initiate a landmark randomized, pivotal trial where a positive outcome will establish this technology as a primary therapy option for the treatment of ischemic heart failure patients," Abraham added.