Remember the Parachute® Ventricular Partitioning Device for the treatment of heart failure, from CardioKinetix Inc.? We’ve covered it a few times over the last few years, since it started its European trials in 2012. Now the company is looking east with the announcement of the first enrollments in PARACHUTE China, a multi-center trial.
Left ventricular enlargement is a common condition associated with heart disease including heart attacks. When this happens the patient suffers a decrease in cardiac output, progressive signs of heart failure including symptoms such as shortness of breath.
Treatment options for patients whose ventricle has enlarged and who suffer from heart failure are limited, and include implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy device (CRT-D). The Parachute device aims to physically reverse the symptoms of left ventricular expansion by effectively partitioning off the damaged section of heart wall. It is the first minimally invasive catheter-based treatment to do so, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and aiming to restore its geometry and function.
The PARACHUTE China study will enroll NYHA II to ambulatory IV ischemic heart failure patients 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. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
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.
The first ten patients have already been treated in Beijing at Peking University and Fu Wai Hospital, and in Shanghai at Shanghai Tenth People’s Hospital.
Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences, principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in China with my colleagues, where there is a significant need for better treatments for heart failure. I am very proud that the first clinical trial cases were performed last week with such high interest by the study investigators, building upon the early, positive experience with the Parachute by leading cardiovascular centers in China.”
“The initiation of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are proud of our efforts to bring the Parachute technology to market on three continents. The initiation of the China trial, along with the active enrollment in our PARACHUTE IV U.S. pivotal trial and the initial commercialization in key European centers under CE Mark, illustrate our commitment to developing the Parachute therapy for heart failure globally.”
Source: CardioKinetix, Inc., Business Wire