September 2, 2020
BioVentrix Resumes Pivotal ALIVE Trial Following COVID-19 Pause
September 2, 2020—BioVentrix, Inc. announced that the company has resumed the pivotal ALIVE trial studying the company’s LIVE (less-invasive ventricular enhancement) therapy using the Revivent TC transcatheter ventricular enhancement system. Elective procedures were paused because of the COVID-19 pandemic and related restrictions. The first patient procedures completed since the pause were performed at St. Luke’s Medical Center in St. Louis, Missouri, and at the Cardiovascular Institute of the South in Houma, Louisiana.
The trial is planned to enroll 120 patients at up to 25 sites in the United States. Coprincipal investigators of the ALIVE trial are Gregg Stone, MD, and Andrew S. Wechsler, MD.
The ALIVE trial is designed to demonstrate the safety and effectiveness of the Revivent TC system to treat patients with ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV). In the procedure, microanchors are implanted in the LV to exclude scarred myocardium from the healthy tissue.
Primary endpoint analysis will be conducted at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association class compared with baseline, exercise capacity, and rehospitalization.
BioVentrix CEO Kenneth Miller stated in the company’s announcement, “COVID-19 has been reported to cause or worsen heart damage, and with the progressive nature of heart failure, delays in treatment can worsen the prognosis for patients. We are pleased that our partner centers are able to resume offering LIVE therapy as an investigational treatment through the ALIVE trial for these patients in need. We expect several other centers to perform cases in the coming weeks.”