The TRICURE US IDE Pivotal Study
NCT07528326 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 831
Last updated 2026-05-05
Summary
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
Conditions
- Tricuspid Regurgitation (TR)
Interventions
- DEVICE
-
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
- DEVICE
-
Edwards EVOQUE TTVR System
Edwards EVOQUE TTVR System
- DEVICE
-
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
Sponsors & Collaborators
-
TRiCares
lead INDUSTRY
Principal Investigators
-
Pradeep Yadav, MD · Piedmont Hospital
-
Neil Fam, MD · Unity Health Toronto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-31
- Primary Completion
- 2031-09-30
- Completion
- 2035-09-30
- FDA Device
- Yes
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