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TVMR With the INNOVALVE System Trial - Early Feasibility Study
Sponsor: Edwards Lifesciences
Summary
Study to evaluate the safety and performance of the INNOVALVE system
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2022-09-01
Completion Date
2031-07-01
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
INNOVALVE system
INNOVALVE system
Locations (17)
Cedars-Sinai
Los Angeles, California, United States
Naples Comprehensive Health
Naples, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern
Chicago, Illinois, United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
Northwell Health
Manhasset, New York, United States
Cornell
New York, New York, United States
NewYork-Presbyterian / Columbia University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Oregon Health & Science Universtiy
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States