Recruiting
The TRICURE US IDE Pivotal Study
TRiCares · NCT07528326
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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 831
- US sites recruiting
- 1
- Study start
- July 8, 2026
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: TRiCares Topaz TTVR System; Edwards EVOQUE TTVR System; TRiCares Topaz TTVR System
Conditions: Tricuspid Regurgitation (TR)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Piedmont Heart Institute
Atlanta, GA 30309
Study contacts (from the official record)
- Stephanie Cihlar · 763-227-7833 · cihlar@tricares.de