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BioVentrix Revivent TC™ System Clinical Study
Sponsor: BioVentrix
Summary
A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.
Official title: Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2017-08-29
Completion Date
2027-06-30
Last Updated
2023-08-22
Healthy Volunteers
No
Conditions
Interventions
Revivent TC
Treatment of LV scar
Locations (30)
University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute
Phoenix, Arizona, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
Baptist Hospital of Maimi
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
WellStar Health System
Marietta, Georgia, United States
Memorial Medical Center
Springfield, Illinois, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CHI St. Luke's Health-Baylor St. Luke's Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Winchester Medical Center
Winchester, Virginia, United States
Nemocnice Na Homolce
Prague, Czechia
Hygeia Hospital
Athens, Greece
Interbalkan Medical Center
Thessaloniki, Greece
Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom