RecruitingNot ApplicableNCT06813820

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Sponsor

BioVentrix

Enrollment

135 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

CHF Left Ventricle Dilated Left Ventricle Remodeling

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 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 Criteria13

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

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Interventions

DEVICERevivent System

BioVentrix has developed the Revivent System to mirror Surgical Ventricular Restoration (SVR). The Revivent System is used to place permanent cardiac implants to the epicardial surface for the purpose of reconfiguring abnormal cardiac geometry that is contributing to the dysfunction.