NCT07528326 · TRiCares
The TRICURE US IDE Pivotal Study
(TRICURE US IDE)
What this 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.
View original scientific description
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.
Interventions
DEVICE
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
DEVICE
Edwards EVOQUE TTVR System
Edwards EVOQUE TTVR System
DEVICE
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
Primary outcome measures
Rate of Major Adverse Events (MAE)
Time frame: 30 days post-procedure
Composite Endpoint
Time frame: 1 year post-procedure
All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2026 · Source of record for eligibility and locations