Actively Recruiting
The TRICURE EFS Study
Led by TRiCares · Updated on 2026-04-14
15
Participants Needed
9
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
CONDITIONS
Official Title
The TRICURE EFS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Piedmont Healthcare Inc.
Atlanta, Georgia, United States, 30309
Actively Recruiting
2
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
5
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
6
Montefiore
The Bronx, New York, United States, 10461
Actively Recruiting
7
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
8
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
St. Michaels Hospital
Toronto, Ontario, Canada
Actively Recruiting
Research Team
E
Esther Gerteis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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