Less invasive ventricular enhancement using the Revivent System

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

This trial tests whether adding the Revivent structural repair system to standard heart-failure medicines helps people with weakened, dilated left ventricles and an anterior/apical scar or aneurysm.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioVentrix (industry)
• Locations: 6 sites (Phoenix, Arizona and 5 other locations)
• Trial ID: NCT06813820 on ClinicalTrials.gov

What this trial studies

RELIVE is a prospective, multicenter, randomized trial that will assign about 135 patients in a 2:1 ratio to the Revivent System plus guideline-directed medical therapy (GDMT) or GDMT alone. The study enrolls patients with anterior/apical left ventricular scar or aneurysm, reduced ejection fraction (<40%), and enlarged end-systolic volumes (LVESVi ≥60 mL/m2) who remain symptomatic despite GDMT. Safety will be compared against a surgical ventriculoplasty performance goal at 30 days, with primary efficacy assessed at one year and an interim efficacy check at six months. Patients will undergo baseline imaging and functional testing and then scheduled follow-up visits to capture clinical, imaging, and quality-of-life outcomes.

Who should consider this trial

Good fit: Adults with anterior/apical (± adjacent regions) LV scar or aneurysm, LVEF under 40%, LVESVi ≥60 mL/m2, NYHA class III–IV symptoms despite adequate GDMT, able to complete baseline testing and follow-up, and willing to consent are ideal candidates.

Not a fit: Patients without a discrete anterior/apical scar or aneurysm, those with predominantly diffuse myocardial damage, preserved LVEF, small LV volumes, significant calcification of the scar, or contraindications to the device or required procedures are unlikely to benefit.

Why it matters

Potential benefit: If successful, combining the Revivent System with medicines could reduce left ventricular size, improve symptoms and quality of life, and offer a less invasive alternative to surgical ventricular restoration.

How similar studies have performed: Surgical ventricular restoration has demonstrated clinical effects historically, and small nonrandomized or single-arm experiences with catheter-based/explant-assisted systems like Revivent have shown promise, but randomized evidence for this device is limited.

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

Where this trial is running

Phoenix, Arizona and 5 other locations

• Banner University Medical Center — Phoenix, Arizona, United States (RECRUITING)
• Baptist Health South Florida — Miami, Florida, United States (RECRUITING)
• University of Chicago — Chicago, Illinois, United States (RECRUITING)
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (RECRUITING)
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (RECRUITING)
• Penn State Health — Hershey, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Vinod THourani, MD — Piedmont Healthcare
• Study coordinator: Steve Chartier

Conditions: Left Ventricle Remodeling, Left Ventricle Dilated, CHF, Left Ventricle Reverse remodeling