AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

RecruitingNAAges 18 Years - anyAllBioVentrix
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • Revivent System
📍

Where

6 sites
Banner University Medical Center
Phoenix, United States
Baptist Health South Florida
Miami, United States
University of Chicago
Chicago, United States
Saint Luke's Hospital of Kansas City
Kansas City, United States
Oklahoma Heart Hospital
Oklahoma City, United States
Penn State Health
Hershey, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy