U.S., Feb. 8 -- ClinicalTrials.gov registry received information related to the study (NCT06813820) titled 'RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial' on Feb. 03.
Brief Summary: A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.
The purpose of the study is to assess the safety and effectiveness of the BioVentrix...