NCT06813820 · BioVentrix
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
(RELIVE)
What this study is about
A forward-looking, multi-center randomly assigned trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomly assigned 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 goal measurement will be evaluated at 30 days.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years old or older
- LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
- 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 criteria
- as evidenced by cardiac imaging)
- Left Ventricular Ejection Fraction \< 40%
- Left ventricular end-systolic volume index ≥60 mL/m2
- Suffering from heart failure symptoms as defined by NYHA Classification \> 2 not responsive to medical therapy
- Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit)
- Patient is on adequate Guideline Directed Medical Therapy (GDMT)
- Subject or a legally authorized representative must provide written informed consent
- Agree to required follow-up visits
- 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:
- Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment
- Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical)
- Mitral Regurgitation greater than moderate (\>2+)
- Need for coronary revascularization, in the opinion of the investigator
- Peak Systolic Pulmonary Arterial Pressure \> 70 mm Hg via echo or right heart catheterization
- Myocardial Infarction within 90 days prior to enrollment
- Within the last six months, a prior CVA or TIA, or intracranial hemorrhage
- Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission
- Severe pulmonary disease that would preclude general anesthesia
- Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac
- Chronic renal failure with a GFR\<30ml/min
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
Where
- Phoenix, Arizona
- Miami, Florida
- Chicago, Illinois
- Kansas City, Missouri
- Oklahoma City, Oklahoma
- Hershey, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations