CardioKinetix has announced three-month clinical and echocardiographic results of PARACHUTE China, a study of 31 Chinese patients treated consecutively with the company’s Parachute ventricular partitioning device.
“The results of this study, which met its primary and secondary endpoints, continue to substantiate the safety profile and effectiveness of the Parachute as a viable minimally invasive ventricular partitioning device for patients with ischaemic heart failure,” said Gao Runlin, chief cardiologist at Fu Wai Hospital, Chinese Academy of Medical Sciences, and co-principal investigator of the trial, who presented the results at the China Interventional Therapeutics (CIT) 2015 conference in Beijing. “The very compelling data from these Chinese patients demonstrates the clear promise of this breakthrough technology and is consistent with previous data reported from Europe and the USA.”
The primary endpoint of left ventricular end systolic volume index (LVESVi) reduction as compared to baseline was met by a reduction from 78.2±20.3ml/m2 at baseline to 53.4±17.4ml/m2 at three-month follow-up, which was found to be highly significant (p<0.0001).
CardioKinetix said that the three-month highlights from the data include:
- Procedural success rate of 97%
- Secondary safety endpoint: device or procedure-related MACE rate of 3%
- Secondary efficacy endpoints achieved
- NYHA functional class improved from 2.1 to 1.4 (p<0.001)
- EQ5D visual analogue scale score improved from 64 to 76 (p<0.01)
- Haemodynamic improvement
- Ejection fraction improved from 29.8% to 36.1% (p<0.0001)
- Wall Motion Severity Index improved from 2.6 to 2.0 (p<0.0001)
- Stroke Work indexed to end diastolic volume improved from 29.4mmHg to 35.9mmHg (p<0.001).
“The PARACHUTE China trial is the fourth trial to demonstrate statistically and clinically meaningful results from our clinical programme. The achievement of meeting the primary and secondary endpoints of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and chief executive officer of CardioKinetix. “We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device where already more than 50 patients have been treated through clinical trials or special access programmes from nine hospitals.”