The TRICURE US IDE Pivotal Study (TRICURE US IDE)

April 29, 2026 updated by: TRiCares

TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The TRICURE US IDE Pivotal Study is a prospective, global, multi-center, randomized (1:1) controlled study (RCT) designed to evaluate the safety and effectiveness of the TRiCares Topaz TTVR System compared to the Edwards EVOQUE TTVR System in subjects with severe or greater tricuspid regurgitation.

Study Type

Interventional

Enrollment (Estimated)

831

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is ≥ 18 years of age
  • Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy
  • Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team

Exclusion Criteria:

  • Patient has a tricuspid device currently in place
  • Patient has anatomical contraindications
  • Patient is in need of urgent surgery
  • Patient has a left ventricular ejection fraction of < 25%
  • Patient has life expectancy of < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRiCares Topaz TTVR
Transcatheter tricuspid valve replacement with TRiCares Topaz TTVR
Device: TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
Active Comparator: Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR
Device: Edwards EVOQUE TTVR System
Edwards EVOQUE TTVR System
Experimental: Single Arm Registry
Patients eligible to receive the TRiCares Topaz TTVR system, but not eligible for the Edwards EVOQUE system will be enrolled in the non-randomized, single-arm registry and treated with Topaz TTVR.
Device: TRiCares Topaz TTVR System
TRiCares Topaz TTVR System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Events (MAE)
Time Frame: 30 days post-procedure
30 days post-procedure
Composite Endpoint
Time Frame: 1 year post-procedure
All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention
1 year post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in qualify of life (QoL)
Time Frame: 1 year post-procedure
as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
1 year post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRiCares

Investigators

  • Principal Investigator: Pradeep Yadav, MD, Piedmont Hospital
  • Principal Investigator: Neil Fam, MD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2035

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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