BioVentrix starts enrolment in clinical trial of ischemic cardiomyopathy device
US-based firm BioVentrix has started patient enrolment in the ALIVE clinical trial of the Revivent TC transcatheter ventricular enhancement system to treat ischemic cardiomyopathy.
The Revivent TC system is designed to facilitate hybrid closed-chest procedure, where a catheter-based approach is used to place small titanium anchors along the outer surface and one of the interior walls of the heart.
The anchors are later pulled towards one another, avoiding the scarred and non-functioning heart wall.
Planned to recruit 120 subjects at approximately 20 sites in the US and the UK, the ALIVE trial will evaluate the safety and effectiveness of the system with primary endpoint measurement after one year.
Consultant cardiothoracic surgeon Dr Steven Tsui and consultant interventional cardiologist Dr Michael O'Sullivan have implanted the device in the first ischemic heart failure patient at Papworth Hospital in Cambridge, UK.
Three micro-anchor pairs have been used during the implantation, which reshaped the left ventricle, reduced the left ventricular end systolic volume index (LVESVI), and enhanced the ejection fraction (EF).
Dr O'Sullivan said: "The transcatheter delivery system allows for more ischemic heart failure patients to be treated with reduced procedural risk relative to conventional surgery.
“Most importantly, this procedure enabled us to achieve a considerable amount of LV volume reduction without the need for open heart surgery or cardiopulmonary bypass.”
The trial’s endpoints are positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) class, six-minute walk test, and rehospitalisation.