Topaz TTVR vs EVOQUE TTVR for severe tricuspid regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, global, multi-center randomized study comparing the TRiCares Topaz TTVR system to the Edwards EVOQUE TTVR system in patients with severe or greater tricuspid regurgitation. Participants are assigned 1:1 to receive either device, and the trial focuses on safety and effectiveness outcomes. Eligible patients are adults with symptomatic TR despite optimal medical therapy and deemed suitable for TTVR by their Heart Team. Key exclusion criteria include existing tricuspid devices, anatomical contraindications, need for urgent surgery, LV ejection fraction <25%, or limited life expectancy (<1 year). The study is led by TRiCares with sites including Piedmont Heart Institute in Atlanta.

Why it matters

Who can join: the full rules

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

Where it's running

• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Pradeep Yadav, MD — Piedmont Hospital
• Study coordinator: Stephanie Cihlar
• Email: cihlar@tricares.de
• Phone: 763-227-7833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.