BioVentrix has announced the resumption of cases in the pivotal ALIVE Trial studying Less Invasive Ventricular Enhancement, or LIVE Therapy, using the Revivent TC transcatheter ventricular enhancement system. The first patient procedures completed since elective procedures were paused due to COVID-19 have taken place at St Luke’s Medical Center, St Louis, USA and at the Cardiovascular Institute of the South in Houma, USA.
“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,” said BioVentrix CEO Kenneth Miller. “We expect several other centres to perform cases in the coming weeks.”
The ALIVE Trial is designed to demonstrate the safety and effectiveness of the Revivent TC System, a minimally invasive, closed-chest transcatheter procedure designed to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV). In the procedure, micro-anchors are implanted in the LV to exclude scarred myocardium from the healthy tissue.
The ALIVE Trial plans to enroll 120 patients at up to 25 sites in the USA 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 compared to baseline, exercise capacity, and rehospitalisation. The co-principal investigators of the ALIVE Trial are Gregg Stone, of the Mount Sinai Health System, New York, USA and Andrew Wechsler, of Drexel University College of Medicine, Philadelphia, USA.