Actively Recruiting
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Led by BioVentrix · Updated on 2026-02-20
135
Participants Needed
6
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar in the left ventricle
- Scar involving anterior, apical, or anterolateral with or without septal regions of the left ventricle confirmed by cardiac imaging
- Left Ventricular Ejection Fraction less than 40%
- Left ventricular end-systolic volume index 60 mL/m2 or higher
- Heart failure symptoms classified as NYHA class greater than 2 not responsive to medical therapy
- Completion of 6 Minute Walk Test and Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life assessment
- Currently receiving adequate Guideline Directed Medical Therapy (GDMT)
- Provided written informed consent
- Agree to required follow-up visits
- Female participants of childbearing potential do not plan pregnancy for at least one year after the procedure and have a negative pregnancy test within seven days before the procedure
You will not qualify if you...
- Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placed 90 days or less before enrollment
- Valvular heart disease requiring intervention as determined by the investigator
- Mitral Regurgitation greater than moderate (>2+)
- Need for coronary revascularization as determined by the investigator
- Peak Systolic Pulmonary Arterial Pressure over 70 mm Hg
- Myocardial Infarction within 90 days before enrollment
- Prior stroke, transient ischemic attack, or intracranial hemorrhage within six months
- Life expectancy less than one year due to co-morbid disease or active malignancy not in remission
- Severe pulmonary disease preventing general anesthesia
- Any solid organ transplant recipient or on a waiting list for transplant other than cardiac
- Chronic renal failure with GFR less than 30 ml/min
- Currently participating in another clinical trial not yet completed its primary endpoint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Banner University Medical Center
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Baptist Health South Florida
Miami, Florida, United States, 33143
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64131
Actively Recruiting
5
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
6
Penn State Health
Hershey, Pennsylvania, United States, 717033
Actively Recruiting
Research Team
S
Steve Chartier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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