Status:
RECRUITING
The TRICURE EFS Study
Lead Sponsor:
TRiCares
Conditions:
Tricuspid Valve Regurgitation
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06506942
Start Date
September 11 2024
End Date
March 1 2031
Last Update
December 17 2025
Active Locations (8)
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1
Piedmont Healthcare Inc.
Atlanta, Georgia, United States, 30309
2
Northwestern
Chicago, Illinois, United States, 60611
3
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States, 48109
4
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407