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

February 19, 2026 updated by: BioVentrix
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Banner University Medical Center
        • Principal Investigator:
          • Radha Gopalan, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33143
        • Recruiting
        • Baptist Health South Florida
        • Contact:
        • Principal Investigator:
          • Masaki Nakamura, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Christopher Salerno, MD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Heart Hospital
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 717033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT)
Medical Intervention through a mini thoracotomy, placement of anchors to plicate the scarred areas of the heart thereby reducing the left ventricle size and improving left ventricle mechanics. Subjects would continue on Guideline Directed Medical Therapy (GDMT)
Device: Revivent 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.
No Intervention: Guideline Directed Medical Therapy (GDMT) only
Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Events Composite Performance Goal
Time Frame: 30 days
Composite of Major Adverse Events at 30 days comprised of Clinical Events Committee (CEC) Adjudication of Mortality, Myocardial Infarction (MI), Major Stroke, Prolonged Intubation >48hrs, Need for Inotropic support >24hrs, Mech circulatory support intra or post op, BARC 4 or 5 bleeding, reoperation, serious infection related to device or procedure, Cardiac tamponade, or Initiation of renal replacement therapy, with a Performance Goal (PG) of 70% (upper bound of the 97.5% one sided CI)
30 days
Composite Effectiveness Endpoint
Time Frame: 6 Months
Using Finkelstein Schoenfeld (FS) hierarchical approach. This approach compares each treatment subject versus each control subject in a hierarchal fashion beginning with Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio.
6 Months
Composite Effectiveness Endpoint
Time Frame: 12 Months
Using Finkelstein Schoenfeld (FS) hierarchical approach - Cardiovascular Mortality, Heart Transplant, Left Ventricular Assist Device (LVAD) Implantation, Hospital Readmission, Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioVentrix

Investigators

  • Principal Investigator: Marat Fudim, MD, Duke University
  • Principal Investigator: Vinod Thourani, MD, Piedmont Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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