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RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Recruiting
Who can join
Ages 18 and older · All sexes
Full 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 childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure Exclusion Criteria: Candidates will be excluded from the study if ANY of the following conditions is present: 1. Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment 2. Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical) 3. Mitral Regurgitation greater than moderate (\>2+) 4. Need for coronary revascularization, in the opinion of the investigator 5. Peak Systolic Pulmonary Arterial Pressure \> 70 mm Hg via echo or right heart catheterization 6. Myocardial Infarction within 90 days prior to enrollment 7. Within the last six months, a prior CVA or TIA, or intracranial hemorrhage 8. Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission 9. Severe pulmonary disease that would preclude general anesthesia 10. Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac 11. Chronic renal failure with a GFR\<30ml/min 12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
About the study
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.
What is being tested
- Revivent System (device)
Sponsor: BioVentrix · Participants: 135 · Started: Sep 29, 2025
Contact the study team
- Steve Chartier · Phone: (925) 830-1000
Official record on ClinicalTrials.gov — NCT06813820
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.