Randomized Evaluation and Verification of Ventricular Enhancement

NCT ID: NCT03845127

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Ischemic Cardiomyopathy; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Revivent TC Ventricular Enhancement System plus 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.

Group Type: EXPERIMENTAL

Revivent TC Ventricular Enhancement System

Intervention Type: DEVICE

Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.

GDMT

Intervention Type: DRUG

Guideline Directed Medical Therapy

GDMT Only

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

Group Type: ACTIVE_COMPARATOR

GDMT

Intervention Type: DRUG

Guideline Directed Medical Therapy

Interventions

Revivent TC Ventricular Enhancement System

Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.

Intervention Type: DEVICE

GDMT

Guideline Directed Medical Therapy

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioVentrix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Anker, MD

Role: PRINCIPAL_INVESTIGATOR

Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie

Volkmar Falk, MD

Role: PRINCIPAL_INVESTIGATOR

Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin

Locations

German Heart Institute Berlin and Charité University Medicine Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

CIP-0080

Identifier Type: -

Identifier Source: org_study_id