Randomized Evaluation and Verification of Ventricular Enhancement

• Status: Enrolling by invitation
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioVentrix
• Collaborator: Imaging Clinical Trial Services GmbH, Meditrial Europe Ltd.

Criteria

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