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Randomized Evaluation and Verification of Ventricular Enhancement

NCT03845127 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-04-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • BioVentrix

    lead INDUSTRY

Principal Investigators

  • Stefan Anker, MD · Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie

  • Volkmar Falk, MD · Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03845127 on ClinicalTrials.gov