Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study

CIP-0080

A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone.

2020-01-01

2024-12-31

2027-12-31

Active (not recruiting)

14

Inclusion Criteria: * Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle. Exclusion Criteria: * Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities; * Inadequate myocardial viability in regions remote from the scar. * Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels; * Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment; * Patient intolerance or unwillingness to take anti-coagulation medication; * Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement; * Pulmonary Arterial Pressure \> 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy; * Myocardial Infarction within 90 days prior to the procedure; * Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement; * Chronic renal failure with a serum creatinine \>2 mg/dL; * Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation. * Baseline 6-minute walk distance of \>450m

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2:1 Randomized Study Design. Crossover permitted after 6 months.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ESTIMATED'}}

2023-08-23