CardioKinetix Inc. Initiates Landmark Study of First-of-Its-Kind Treatment for Heart Failure in the United States
1/8/2013 9:38:15 AM
MENLO PARK, Calif.--(BUSINESS WIRE)--CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. trial of the minimally invasive Parachute™ Ventricular Partitioning Device for the treatment of heart failure. PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 500 patients with ischemic heart failure at up to 65 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
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