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
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences

This content was sourced from clinicaltrials.gov

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