Clinical Study of Edwards Cardioband FIT Valve Repair System
Status: Recruiting
Location: See all (11) 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
Georgia
Piedmont Heart Institute
NOT_YET_RECRUITING
Atlanta
Illinois
Northwestern University
ACTIVE_NOT_RECRUITING
Chicago
Minnesota
Mayo Clinic
RECRUITING
Rochester
New Jersey
Morristown Medical Center
ACTIVE_NOT_RECRUITING
Morristown
New York
Columbia University Medical Center /New York Presbyterian Hospital
ACTIVE_NOT_RECRUITING
New York
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Lankenau Medical Center
RECRUITING
Wynnewood
Texas
Heart Hospital Baylor Plano
RECRUITING
Plano
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
University of Virginia Health System
ACTIVE_NOT_RECRUITING
Charlottesville
Washington
University of Washington
ACTIVE_NOT_RECRUITING
Seattle
Contact Information
Primary
TMTT Clinical
TMTT_Clinical@edwards.com
949-250-2500
Time Frame
Start Date: 2018-07-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 55
Treatments
Experimental: Treatment
Treatment with the Edwards Cardioband FIT Repair System
Authors
James McCabe, Konstantinos Koulogiannis, Tamim Nazif, Susheel Kodali, Robert Kipperman, Georg Mackensen, Paul Grayburn, Vuyisile Nkomo, Martin Leon, Charles Davidson, Sorin Pislaru, Marc Goldschmidt, Juan Crestanello, Sunil Mankad, John Brown, Kent Jones, Mark Ricciardi, Rebecca Hahn, John Stulak, Bruce Reid, Philippe Genereux, Hector Michelena, Lillian Aldaia, Leo Marcoff, Grace Lin, Gorav Ailawadi, Seth Uretsky
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences