The TRICURE EFS Study
NCT06506942 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-04-14
Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Conditions
- Tricuspid Valve Regurgitation
- Heart Valve Diseases
- Cardiovascular Diseases
Interventions
- DEVICE
-
Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Sponsors & Collaborators
-
TRiCares
lead INDUSTRY
Principal Investigators
-
Susheel Kodali, MD · Columbia University Medical Center/ NewYork Presbyterian Hospital
-
Gorav Ailawadi, MD · University of Michigan Hospital and Health Systems
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-11
- Primary Completion
- 2027-03-31
- Completion
- 2031-03-31
- FDA Device
- Yes
Countries
- United States
- Canada
Study Locations
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