BioVentrix has received US Food and Drug Administration (FDA) investigational device exemption approval to initiate its pivotal ALIVE (American Less Invasive Ventricular Enhancement) clinical trial.
The trial is designed to demonstrate the safety and effectiveness of the Revivent TC transcatheter ventricular enhancement system; a hybrid closed-chest transcatheter procedure to treat patients suffering from ischaemic cardiomyopathy by reshaping and restoring the left ventricle. This is accomplished by implanting micro-anchoring pairs in the left ventricle to exclude scarred myocardium from the healthy tissue.
Lead US principal investigator, Andrew Wechsler, says, “The current therapy—surgical ventricular reconstruction—is effective, yet it is highly invasive and limited in terms of patients being able to withstand the procedure. This investigational device exemption approval provides another treatment option that physicians can consider when exploring the best therapy solution for heart failure patients.”
The ALIVE trial plans to enrol 120 patients at up to 20 sites nationwide with a primary endpoint analysis at one year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association (NYHA) Class, six-minute walk test, and rehospitalisation.
“The Revivent TC system has recently demonstrated efficacy in clinical trials performed in the EU,” says Ryan Brown, cardiologist and vice president of Medical Affairs for BioVentrix. “This technology provides a less invasive means for left ventricle scar reduction/exclusion in patients with prior myocardial infarction and left ventricle dysfunction.”
According to a company release, BioVentrix has shown in multiple clinical trials in Europe that the exclusion of scar tissue from the left ventricle cavity in patients suffering from ischaemic cardiomyopathy and heart failure symptoms results in substantial improvements in left ventricle volume, NYHA Class, six-minute walk tests, and quality of life. Additionally, previous studies reported in the surgical literature have shown that a significant left ventricle volume reduction conveys a survival benefit for treated patients.