BioVentrix has enrolled the first patient in the US arm of the ALIVE pivotal clinical trial of the Revivent TC TransCatheter Ventricular Enhancement System to treat patients suffering from heart failure (HF) symptoms related to cardiomyopathy.
The trial is designed to demonstrate the safety and effectiveness of the Revivent TC, which uses a hybrid closed-chest procedure to treat patients.
The company has also secured investigational device exemption (IDE) approval for the trial from the US Food and Drug Administration (FDA).
Interventional cardiologist Dr Catalin Toma and cardiothoracic surgeon Dr Christopher Sciortino have carried out the Less Invasive Ventricular Enhancement (LIVE) procedure at the UPMC Heart and Vascular Institute.
During the procedure, the device was successfully implanted with three micro-anchor pairs in a 42-year-old female patient suffering from ischemic heart failure.
Toma said: “UPMC remains at the forefront of implementing promising less invasive therapies to address the need for better heart failure treatment.
“We are pleased to be the first US centre to implant the Revivent TC System as part of the ALIVE clinical trial.
“The procedure aims to reshape the left ventricle, decrease the left ventricular end systolic volume index (LVESVI), and increase the ejection fraction (EF). The patient was discharged shortly after the procedure and is recovering well.”
A total of 120 patients are planned to be enrolled in the ALIVE trial at up to 20 sites in the US and the UK with a primary endpoint analysis at one year.
The endpoints of the trial include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, a six-minute walk test, and rehospitalisation.