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← Trials
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The TRICURE US IDE Pivotal Study

RecruitingNAAges 18 Years - anyAllTRiCares
NCT07528326 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • TRiCares Topaz TTVR System
  • Edwards EVOQUE TTVR System
  • TRiCares Topaz TTVR System
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Where

1 site
Piedmont Heart Institute
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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