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NOT YET RECRUITING
NCT07528326
NA

The TRICURE US IDE Pivotal Study

Sponsor: TRiCares

View on ClinicalTrials.gov

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.

Official title: TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

831

Start Date

2026-10

Completion Date

2035-09

Last Updated

2026-05-05

Healthy Volunteers

No

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