Tricuspid Regurgitation (TR)TRICURE US IDENCT07528326
The TRICURE US IDE Pivotal Study
A study testing TRiCares Topaz TTVR System and Edwards EVOQUE TTVR System in people with Tricuspid Regurgitation (TR), run by TRiCares at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- TRiCares Topaz TTVR System and Edwards EVOQUE TTVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 831 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to Sep 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
About this study
Official title: TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study
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.
Read the 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.
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRiCares Topaz TTVR SystemDevice
TRiCares Topaz TTVR System
Edwards EVOQUE TTVR SystemDevice
Edwards EVOQUE TTVR System
TRiCares Topaz TTVR SystemDevice
TRiCares Topaz TTVR System
| Study group | Role | What they receive |
|---|---|---|
| TRiCares Topaz TTVR | Experimental | Transcatheter tricuspid valve replacement with TRiCares Topaz TTVR Receives: Device: TRiCares Topaz TTVR System |
| Edwards EVOQUE TTVR | Active comparator | Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR Receives: Device: Edwards EVOQUE TTVR System |
| Single Arm Registry | Experimental | Patients eligible to receive the TRiCares Topaz TTVR system, but not eligible for the Edwards EVOQUE system will be enrolled in the non-randomized, single-arm registry and treated with Topaz TTVR. Receives: Device: TRiCares Topaz TTVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Events (MAE)
Measured: 30 days post-procedure
Composite Endpoint
All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention
Measured: 1 year post-procedure
Secondary outcomes (1)
Change in qualify of life (QoL)
as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Measured: 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start8 Jul 2026
- Primary completionSep 2031 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 831 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRiCares
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pradeep Yadav, MD, Principal investigator, Piedmont HospitalNeil Fam, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528326
- Sponsor's protocol ID
- 2501
- Acronym
- TRICURE US IDE
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided