RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Overview

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.

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).

Interventions

• 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.

Primary outcome measures

• Major Adverse Events Composite Performance Goal [Time frame: 30 days]
• Composite Effectiveness Endpoint [Time frame: 6 Months]
• Composite Effectiveness Endpoint [Time frame: 12 Months]

Eligibility criteria

Inclusion criteria

• 18 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 6 centers

• Banner University Medical Center — Phoenix
• Baptist Health South Florida — Miami
• University of Chicago — Chicago
• Saint Luke's Hospital of Kansas City — Kansas City
• Oklahoma Heart Hospital — Oklahoma City
• Penn State Health — Hershey

Identifiers

NCT: NCT06813820 · CIP-0100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗