Recruiting

TRiCares Topaz

Sponsor:

TRiCares

Code:

NCT07528326

Conditions

Tricuspid Regurgitation (TR)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TRiCares Topaz TTVR System

Edwards EVOQUE TTVR System

TRiCares Topaz TTVR System

Study Details

Brief 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)

Study ID

NCT07528326

Start date

Jul 8, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2035

Anticipated

Primary completion date

Sep, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

831 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TRiCares Topaz TTVR

Transcatheter tricuspid valve replacement with TRiCares Topaz TTVR

active comparator: Edwards EVOQUE TTVR

Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR

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.

Interventions

TRiCares Topaz TTVR System

TRiCares Topaz TTVR System

Edwards EVOQUE TTVR System

Edwards EVOQUE TTVR System

TRiCares Topaz TTVR System

TRiCares Topaz TTVR System

Primary outcome measure

  • Rate of Major Adverse Events (MAE) [ Time Frame: 30 days post-procedure ]
  • Composite Endpoint [ Time Frame: 1 year post-procedure ]

Central Contacts and Locations

Central contacts

Stephanie Cihlar

763-227-7833cihlar@tricares.de

Locations

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

More Information

Sponsor

TRiCares

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by TRiCares on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.