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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study
- ClinicalTrials.gov ID
- NCT07528326
- Acronym / sponsor ID
- TRICURE US IDE / 2501
- Conditions
- Tricuspid Regurgitation (TR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 831 participants (estimated)
- Lead sponsor
- TRiCaresIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRiCares Topaz TTVR | Experimental | Device: TRiCares Topaz TTVR SystemTranscatheter tricuspid valve replacement with TRiCares Topaz TTVR |
| Edwards EVOQUE TTVR | Active comparator | Device: Edwards EVOQUE TTVR SystemTranscatheter tricuspid valve replacement with Edwards EVOQUE TTVR |
| Single Arm Registry | Experimental | Device: TRiCares Topaz TTVR SystemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRiCares Topaz TTVR SystemTRiCares Topaz TTVR System | Device | TRiCares Topaz TTVR |
| Edwards EVOQUE TTVR SystemEdwards EVOQUE TTVR System | Device | Edwards EVOQUE TTVR |
| TRiCares Topaz TTVR SystemTRiCares Topaz TTVR System | Device | Single Arm Registry |
Primary outcome
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
1 secondary outcome
Change in qualify of life (QoL)
Time frame: 1 year post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tricuspid Regurgitation (TR)
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First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
Tricuspid Regurgitation, Tricuspid Insufficiency
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pradeep Yadav, MD principal investigator
Piedmont Hospital
Neil Fam, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Cihlar (763-227-7833, cihlar@tricares.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Events (MAE) (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.