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Randomized Evaluation and Verification of Ventricular Enhancement — REVIVE-HF  

Heart Failure Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03845127
Study type Interventional
Source BioVentrix
Contact
Status Active, not recruiting
Phase N/A
Start date January 1, 2020
Completion date December 31, 2027
View Details
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