CLINICAL TRIAL / NCT06813820

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

  • Interventional
  • Active
  • NCT06813820

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

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.