Thursday, January 08, 2015
CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced the completion of enrollment in PARACHUTE China, a multi-center trial to evaluate the minimally invasive Parachute® Ventricular Partitioning Device for the treatment of heart failure.
Results of PARACHUTE China will be presented at the China Interventional Therapeutics (CIT) 2015 conference, which will take place March 19-22 in Beijing, China.
“The completion of enrollment in the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of 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.”
PARACHUTE China (clinicaltrials.gov/ NCT02240940) enrolled NYHA II to ambulatory IV ischemic heart failure patients with ejection fraction 15-40% to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.
The principal investigator is Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.
Source : http://www.businesswire.com/
