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NCT06813820 | NOT YET RECRUITING | Left Ventricle Remodeling

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Sponsor:

BioVentrix

Brief 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. 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).

Condition or disease

Left Ventricle Remodeling

Left Ventricle Dilated

CHF

Intervention/treatment

Revivent System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 135 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2028-08
Estimated Study Completion Date : 2032-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Location Details

NCT06813820

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