The TRICURE EFS Study

Recruiting now · Not applicable

Conditions studied: Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

In brief

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Key facts

Study ID: NCT06506942
Run by: TRiCares
People needed: 15
Starts: 2024-09-11
Expected to finish: 2031-03-01
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Piedmont Healthcare Inc. — Atlanta, Georgia, United States (enrolling)
Northwestern — Chicago, Illinois, United States (enrolling)
University of Michigan Hospital and Health Systems — Ann Arbor, Michigan, United States (enrolling)
Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York, United States (enrolling)
Montefiore — The Bronx, New York, United States (enrolling)
The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)
St. Michaels Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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