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RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
Sponsor: BioVentrix
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
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