CardioKinetix has started enrolling patients for its PARACHUTE III, a post-market safety surveillance trial, in Germany.
The dual-arm, multi-center, open-label trial, which will enroll up to 100 ischemic heart failure patients, is designed to assess the functionality of Parachute Ventricular Partitioning device with optimal medical therapy.
The primary endpoint of the trial is procedural- and device-related major adverse cardiac events (MACE) through 60 months.
Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).
As part of the PARACHUTE trial, the Parachute devices were implanted at Heidelberg University Clinic in Heidelberg as well as at St. Marien-Hospital Abt. Innere Medizin in Bonn, Germany.
The implanted patients were treated successfully and discharged without any procedure-related complications.
PARACHUTE III study principle investigator and St Thomas Hospital cardiology chairman Martyn Thomas said, "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 company also plans to expand its post-marketing trial effort in Europe by adding hospitals in the UK, Spain, Italy, Belgium, Germany and the Netherlands, in coming months.
The Parachute device is a minimally invasive catheter-based treatment designed to partition the damaged muscle and decrease the overall volume of the left ventricle and restore its geometry and function.
The Parachute device has received CE mark approval in 2011, and is an investigational device limited by federal law to investigational use only in the US.
