Randomized Evaluation and Verification of Ventricular Enhancement

Not Applicable

Withdrawn

• Conditions: Ischemic Cardiomyopathy; Heart Failure
• Interventions: Drug: GDMT; Device: Revivent TC Ventricular Enhancement System

• Registration Number: NCT03845127
• Lead Sponsor: BioVentrix

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2020-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDMT Only	GDMT	Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Revivent TC Ventricular Enhancement System plus GDMT	GDMT	Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Revivent TC Ventricular Enhancement System plus GDMT	Revivent TC Ventricular Enhancement System	Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.

Primary Outcome Measures

Name	Time	Method
6 Minute Walking Distance	3 and 6 months after enrollment	Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.

Secondary Outcome Measures

Name	Time	Method
LVESVI and LVEDVI	3 and 6 months after enrollment	Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline
Quality of Life Index	3 and 6 months after enrollment	Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire.
NYHA Classification	3 and 6 months after enrollment	Changes in NYHA Heart Classification compared to baseline
LVEF	3 and 6 months after enrollment	Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline

Trial Locations

Locations (1)

German Heart Institute Berlin and Charité University Medicine Berlin; 🇩🇪 Berlin, Germany