Less invasive ventricular enhancement using the Revivent System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: schartier@bioventrix.com
• Phone: (925) 830-1000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.