Medical device company CardioKinetix has completed patient enrollment in Parachute China, a multi-center study to assess Parachute Ventricular Partitioning Device to treat heart failure.
The company will present the results at the China Interventional Therapeutics (CIT) 2015 conference, which will be held in Beijing of China, from 19 to 22 March.
CardioKinetix president and CEO Maria Sainz said: "The completion of enrollment in the China study is a major milestone for CardioKinetix.
"We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device and commitment to enrolling the trial so efficiently, and we look forward to releasing the results this spring."
To support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA), the trial enrolled NYHA II to ambulatory IV ischemic heart failure patients with 15% to 40% ejection fraction.
According to the company, the primary endpoint of the trial is reduction in left ventricle end systolic volume index (LVESVi) at three months that will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.
The device received CE mark approval in 2011, while in the US, it an investigational device limited by federal law to investigational use only and is not available for sale.