Randomized Evaluation and Verification of Ventricular Enhancement (REVIVE-HF)

BioVentrix

Status: Withdrawn

Conditions: Heart Failure; Ischemic Cardiomyopathy

Treatments: Device: Revivent TC Ventricular Enhancement System; Drug: GDMT

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03845127

CIP-0080

Details and patient eligibility

About

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.

Full description

The purpose of the study is to demonstrate that treatment with the BioVentrix Revivent TC System is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. This is 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. This study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on GDMT.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Revivent TC Ventricular Enhancement System plus GDMT

Experimental group

Description:

Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.

Treatment:

Drug: GDMT

Device: Revivent TC Ventricular Enhancement System

GDMT Only

Active Comparator group

Description:

Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.

Treatment:

Drug: GDMT