CardioKinetix has commenced enrolment for a post-market safety surveillance trial, PARACHUTE III, of the Parachute ventricular partitioning device, in Germany.
The CE-marked Parachute device facilitates a minimally invasive treatment for patients with heart failure caused by damage to the heart muscle following a heart attack.
PARACHUTE III study principle investigator and chairman at St Thomas Hospital, London, Martyn Thomas, said the Parachute implant system represents an important advancement in treatment options for patients with ischemic heart failure.
"These first procedures in the PARACHUTE III trial represent the beginning of the largest clinical data evaluation for this new therapy to date," Thomas added.
"I am optimistic that the patients treated with the Parachute implant will experience positive results similar to those in prior trials of the device most recently reported during the 2012 EuroPCR meeting."
The dual-arm (Parachute versus optimal medical therapy), open-label, multicentre trial will enrol around 100 patients with ischemic heart failure, at up to 20 centres in Europe.
Procedural- and device-related major adverse cardiac events (MACE) across 60 months are the primary endpoints of the trial.
Hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT) are the other key endpoints.
The device offers a catheter-based treatment to partition the damaged muscle, keeping out the non-functional heart segment from the functional segment, thereby decreasing the overall volume of the left ventricle and restoring its geometry and function.
Heidelberg University Clinic cardiologist Stefan Hardt performed the first implants with Parachute devices as part of the PARACHUTE III trial and reported that all patients were treated successfully and discharged without procedure-related complications.
The company now plans to expand its post-marketing trial efforts in Europe by adding hospitals in the UK, Spain, Italy, Belgium, Germany and Netherlands shortly.