RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Last updated: February 19, 2026
Sponsor: BioVentrix
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Revivent System

Clinical Study ID

NCT06813820
CIP-0100
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 oranterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion asevidenced 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 notresponsive to medical therapy

  7. Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can beperformed 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 oneyear following the index procedure. For a female of childbearing potential, apregnancy test must be performed with negative results known within seven days priorto index procedure

Exclusion

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 priorto enrollment

  2. Valvular heart disease, which in the opinion of the investigator, will requireintervention (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 heartcatheterization

  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 activemalignancy 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 transplantother than cardiac

  11. Chronic renal failure with a GFR<30ml/min

  12. Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: Revivent System
Phase:
Study Start date:
September 29, 2025
Estimated Completion Date:
August 31, 2032

Study Description

The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.

Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE's at 30 days).

Connect with a study center

  • Banner University Medical Center

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Active - Recruiting

  • Baptist Health South Florida

    Miami 4164138, Florida 4155751 33143
    United States

    Active - Recruiting

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City 4393217, Missouri 4398678 64131
    United States

    Active - Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City 4544349, Oklahoma 4544379 73120
    United States

    Active - Recruiting

  • Penn State Health

    Hershey 5193342, Pennsylvania 6254927 717033
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.