Condition: Left Ventricle Remodeling · Left Ventricle Dilated · CHF · Sponsor: BioVentrix
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.
This description comes directly from the study's public registry record.
Steve Chartier · (925) 830-1000 · schartier@bioventrix.com
Always discuss trial participation with your own doctor first.
| Banner University Medical Center | Phoenix, Arizona, United States | Recruiting |
| Baptist Health South Florida | Miami, Florida, United States | Recruiting |
| University of Chicago | Chicago, Illinois, United States | Recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City, Missouri, United States | Recruiting |
| Oklahoma Heart Hospital | Oklahoma City, Oklahoma, United States | Recruiting |
| Penn State Health | Hershey, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06813820