Clinical Study of Edwards Cardioband FIT Valve Repair System
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Clinical Study of the Edwards Cardioband FIT Repair System
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Tricuspid regurgitation (moderate or greater)
• Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
• The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid reconstruction
• Patient is willing and able to comply with all specified study evaluations and provides written informed consent
Locations
United States
Illinois
Northwestern University
Chicago
Minnesota
Mayo Clinic
Rochester
New Jersey
Morristown Medical Center
Morristown
New York
Columbia University Medical Center /New York Presbyterian Hospital
New York
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Lankenau Medical Center
Wynnewood
Texas
Heart Hospital Baylor Plano
Plano
Utah
Intermountain Medical Center
Murray
Virginia
University of Virginia Health System
Charlottesville
Time Frame
Start Date: 2018-07-01
Completion Date: 2031-12-31
Participants
Target number of participants: 75
Treatments
Experimental: Treatment
Treatment with the Edwards Cardioband FIT Repair System
Authors
Charles Davidson, Brian Whisenant, Konstantinos Koulogiannis, Tamim Nazif, Susheel Kodali, Robert Kipperman, Georg Mackensen, Paul Grayburn, Vuyisile Nkomo, Mackram Eleid, Martin Leon, Sorin Pislaru, Marc Goldschmidt, Hector Michelena, James Thomas, Juan Crestanello, William Gray, Sunil Mankad, Kent Jones, Mark Ricciardi, Rebecca Hahn, Gabriel Aldea, John Stulak, Bruce Reid, Philippe Genereux, Lillian Aldaia, Leo Marcoff, James McCabe, Grace Lin, Mark Reisman, Gorav Ailawadi, Seth Uretsky
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences