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The TRICURE US IDE Pivotal Study

NCT07528326 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2026-05-05

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528326 on ClinicalTrials.gov