Randomized Evaluation and Verification of Ventricular Enhancement

NCT03845127 | Withdrawn FDA Device

• 1 other identifier: CIP-0080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy; Heart Failure

Keywords

Ischemic Cardiomyopathy, Heart Failure, Revivent TC System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Life Index

  3 and 6 months after enrollment

• NYHA Classification

  3 and 6 months after enrollment

• LVESVI and LVEDVI

  3 and 6 months after enrollment

• LVEF

  3 and 6 months after enrollment

Study Arms (2)

Revivent TC Ventricular Enhancement System plus GDMT

EXPERIMENTAL

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; Drug: GDMT

GDMT Only

ACTIVE COMPARATOR

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

Drug: GDMT

Interventions

Revivent TC Ventricular Enhancement System DEVICE

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

Revivent TC Ventricular Enhancement System plus GDMT

GDMT DRUG

Guideline Directed Medical Therapy

GDMT Only; Revivent TC Ventricular Enhancement System plus GDMT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BioVentrix: lead

Study Sites (1)

German Heart Institute Berlin and Charité University Medicine Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 Randomized Study Design. Crossover permitted after 6 months.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)