Status: Recruiting
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.
Participants needed: 135
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: BioVentrixUpdated: Feb 20, 2026Locations: 6
Eligibility criteria
18 years old or older [+10]
Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days p... [+11]