NCT06506942NARecruiting
The TRICURE EFS Study
TRiCares
Start Date
9/11/2024
Completion Date
3/1/2031
Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Detailed Description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk
Exclusion Criteria:
* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Interventions
DEVICE
Transcatheter Tricuspid Valve Replacement
Conditions
Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases
Locations
Piedmont Healthcare Inc.
Atlanta, Georgia 30309
United States
Northwestern
Chicago, Illinois 60611
United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan 48109
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York 10032
United States
Montefiore
The Bronx, New York 10461
United States
The Christ Hospital
Cincinnati, Ohio 45219
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
St. Paul's Hospital
Vancouver, British Columbia V6Z1Y6
Canada
St. Michaels Hospital
Toronto, Ontario
Canada