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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Ischemic Cardiomyopathy
• Intervention / Treatment: Device: Revivent TC Ventricular Enhancement System; Drug: GDMT

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • German Heart Institute Berlin and Charité University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Drug: GDMT; Guideline Directed Medical Therapy
Active Comparator: GDMT Only; Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.	Drug: GDMT; Guideline Directed Medical Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioVentrix
• Collaborators: Imaging Clinical Trial Services GmbH, Meditrial Europe Ltd.
• Investigators: Principal Investigator: Stefan Anker, MD, Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie; Principal Investigator: Volkmar Falk, MD, Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Cardiomyopathies
• Other Study ID Numbers: CIP-0080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes