Actively Recruiting
The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
Led by TRiCares · Updated on 2026-04-14
15
Participants Needed
9
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-center study to evaluate the safety and performance of the TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System. This study focuses on adults with severe tricuspid valve regurgitation who are considered at increased operative risk by their medical team. It aims to gather important data about this device, which is used to replace the tricuspid valve through a catheter-based approach. Participants will receive treatment using the TRiCares Topaz Transcatheter Tricuspid Valve Replacement System. This device replaces the damaged tricuspid valve without open-heart surgery by using a transcatheter method. The study involves a single treatment arm where all participants undergo this procedure. During the study, participants will be monitored for safety and device performance, including major adverse events within 30 days after the intervention and immediate device success. Follow-up assessments will include a six-minute walk test, evaluation of tricuspid regurgitation grade, and New York Heart Association functional class measured at 30 days, 6 months, and annually for up to five years. This long-term follow-up will help understand the device's lasting effects and safety profile.
CONDITIONS
Brief Title
The TRICURE EFS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients
- Severe tricuspid regurgitation grade 3 on a scale of 0 to 5
- Evaluated by an institutional Heart Team as being at increased operative risk
You will not qualify if you...
- Need for emergent intervention
- Hemodynamically unstable patient
- Anatomical contraindications for implantation with study device
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo replacement of the tricuspid valve through a transcatheter approach using the study device.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for safety and valve function after the procedure.
Multiple visits up to 30 days post-intervention
Duration - Up to 5 years
Participants are followed to assess functional outcomes and valve performance annually for up to five years after the procedure.
Visits at 6 months and annually for five years post-intervention
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
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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