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ACTIVE NOT RECRUITING
NCT02931240
NA

BioVentrix Revivent TC™ System Clinical Study

Sponsor: BioVentrix

View on ClinicalTrials.gov

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

Interventions

DEVICE

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