Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07528326

The TRICURE US 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Tricuspid Regurgitation (TR) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRiCares Topaz TTVR System

Device

TRiCares Topaz TTVR System

Edwards EVOQUE TTVR System

Device

Edwards EVOQUE TTVR System

Primary outcomes

  1. Rate of Major Adverse Events (MAE)

    Time frame: 30 days post-procedure

  2. Composite Endpoint

    Time frame: 1 year post-procedure

    All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention

Secondary outcomes

  1. Change in qualify of life (QoL)

    Time frame: 1 year post-procedure

    as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Cihlar

CONTACT

[email protected]

763-227-7833

Sponsors and collaborators

Lead sponsor

TRiCares

Industry

Registry information

Official study title

TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study

Acronym: TRICURE US IDE

Important dates

Study start
2026
Primary completion
2031
Study completion
2035
First posted
Apr 14, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.