RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. 18 years old or older 2. LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar 3. LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical or anterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging) 4. Left Ventricular Ejection Fraction \< 40% 5. Left ventricular end-systolic volume index ≥60 mL/m2 6. Suffering from heart failure symptoms as defined by NYHA Classification \> 2 not responsive to medical therapy 7. Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit) 8. Patient is on adequate Guideline Directed Medical Therapy (GDMT) 9. Subject or a legally authorized representative must provide written informed consent 10. Agree to required follow-up visits 11. Female subject of c