Tricuspid Regurgitation (TR)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETRiCares Topaz TTVR System
TRiCares Topaz TTVR System
DEVICEEdwards EVOQUE TTVR System
Edwards EVOQUE TTVR System
Sponsors
TRiCares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events (MAE) | 30 days post-procedure | — |
| Composite Endpoint | 1 year post-procedure | All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in qualify of life (QoL) | 1 year post-procedure | as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline |
Contacts
CONTACTStephanie Cihlar
PRINCIPAL_INVESTIGATORPradeep Yadav, MD
Piedmont Hospital
PRINCIPAL_INVESTIGATORNeil Fam, MD
Unity Health Toronto
Outcome results
None listed