NCT03845127

Randomized Evaluation and Verification of Ventricular Enhancement

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioVentrix · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-02-19
• Last updated: 2025-04-10

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study