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RELIVE Clinical Trial

Randomized Evaluation of Less Invasive Ventricular Enhancement (RELIVE) is a prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.

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.

Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE’s at 30 days).

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