US-based medical device firm CardioKinetix has completed patient enrolment in Parachute China, a multi-centre trial designed to assess the minimally invasive Parachute Ventricular Partitioning Device to treat heart failure.
The trial enrolled New York Heart Association (NYHA) II to ambulatory IV ischemic heart failure patients with ejection fraction 15%-40% to support regulatory submission for the Parachute device to China Food and Drug Administration (CFDA).
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The Parachute device provides the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease overall volume of the left ventricle and restore its geometry and function.
Primary endpoint of the trial is reduction in left ventricular end systolic volume index (LVESVi) at three months, which will be analysed at an echocardiography core lab, Yale Cardiovascular Research Group.
The company said results from the Parachute China trial will be presented at the China Interventional Therapeutics (CIT) 2015 conference, which will take place between 19-22 March in Beijing, China.
CardioKinetix president Maria Sainz said: "The completion of enrolment in the China study is a major milestone for CardioKinetix.
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By GlobalData"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."
In the trial, Fu Wai Hospital chief cardiologist Dr Gao Runlin is serving as principal investigator and Heart Center and Department of Cardiology PKU-1st Hospital director Dr Huo Yong, and Cardiovascular Institute vice-president Dr Yang Yuejin are serving as co-principal investigators.
