United States Arm of ALIVE Study Begins for BioVentrix Revivent TC System
October 4, 2017—BioVentrix, Inc. announced enrollment of the first patient in the United States arm of the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the Revivent TC transcatheter ventricular enhancement system, which is a hybrid closed-chest procedure to treat patients experiencing heart failure symptoms related to cardiomyopathy.
According to the company, the ALIVE trial plans to enroll 120 patients at up to 20 sites in the United States and United Kingdom with a primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association class, 6-minute walk test, and rehospitalization. BioVentrix previously received investigational device exemption approval for the study from the US Food and Drug Administration. The Revivent TC system is approved for sale in Europe; it is not approved for sale in the United States.
According to the company, the device was implanted using the company's less invasive ventricular enhancement, or LIVE, procedure that was performed at the UPMC Heart and Vascular Institute in Pittsburgh, Pennsylvania, by interventional cardiologist Catalin Toma, MD, and cardiothoracic surgeon Christopher Sciortino, MD. The device was successfully implanted with three microanchor pairs in a 42-year-old woman with ischemic heart failure.
In the company's press release, Dr. Toma commented, "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 United States center 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, and increase the ejection fraction. The patient was discharged shortly after the procedure and is recovering well."
Dr. Sciortino added, "The LIVE procedure is less invasive and less traumatic than conventional surgical reconstruction. It expands the patient population that can be treated by reducing the procedural risk. The patient was able to undergo this procedure without having to perform a sternotomy or employ cardiopulmonary bypass."