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RECRUITING
NCT06813820
NA

RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial

Sponsor: BioVentrix

View on ClinicalTrials.gov

Summary

A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2025-09-29

Completion Date

2032-08

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DEVICE

Revivent System

BioVentrix has developed the Revivent System to mirror Surgical Ventricular Restoration (SVR). The Revivent System is used to place permanent cardiac implants to the epicardial surface for the purpose of reconfiguring abnormal cardiac geometry that is contributing to the dysfunction.

Locations (6)

Banner University Medical Center

Phoenix, Arizona, United States

Baptist Health South Florida

Miami, Florida, United States

University of Chicago

Chicago, Illinois, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Penn State Health

Hershey, Pennsylvania, United States