Cardiac therapies developer Ancora Heart has started patient enrolment in the CorCinch EU clinical trial of AccuCinch Ventricular Repair System to treat reduced ejection fraction systolic heart failure (HFrEF).
The AccuCinch investigational system is developed to address the underlying cause of heart failure by repairing the enlarged left ventricle.
The percutaneous ventricular repair device is designed for the treatment of heart failure and functional mitral regurgitation (FMR).
It aims to support the current care solutions for managing heart failure symptoms, and slowing or stopping the disease progression.
The company added that the system may reverse the enlargement of the left ventricle in certain patients. AccuCinch is also intended to offer a non-surgical percutaneous therapy option for patients whose condition could not be addressed with medications and pacemakers.
Ancora Heart president and CEO Jeff Closs said: “AccuCinch promises to be an unprecedented method for improving the care and quality of life for patients with heart failure.
“Enrolling the first systolic heart failure patient in this European study is an important achievement towards our goal of demonstrating that the therapy has the potential to fundamentally improve heart function.”
The first patient for the trial was recruited at Homolka Hospital in Prague, Czech Republic, and the AccuCinch procedure was performed at The Mount Sinai Hospital in New York, US.
Data from the study is expected to provide information about the percutaneous ventricular repair system’s potential benefits.
Study principal investigator Petr Neužil said: “We are pleased to participate in this study because the AccuCinch has the potential to address the shortcomings of current medical, surgical and transcatheter treatments and restore quality of life and longevity for this large patient population.”
The trial will enrol up to 132 patients at heart centres in Europe.