Tricuspid Valve RegurgitationTRICURE EUNCT06581471
The TRICURE EU Pivotal Study
A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Valve Regurgitation and Heart Valve Disease, run by TRiCares at 8 sites in 2 countries.
Trial summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- What is being tested?
- Transcatheter Tricuspid Valve Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 29 Aug 2024to 30 Dec 2030
- 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
- Adult patients
- Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
- Institutional Heart Team evaluates patient as being at increased operative risk
Who cannot join
- Patient in need of emergent intervention
- Patient who is hemodynamically unstable
- Anatomical contraindications for implantation with study device
- Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Belgium6 sites, 6 recruiting
- Recruiting
Algemeen Stedelijk Ziekenhuis
Aalst, 9300
Liesbeth Rosseel, MD, 003253766730, liesbeth.rosseel@asz.be
Liesbeth Rosseel, MD
- Recruiting
ZNA Middelheim
Antwerp
Stefan Verheye, MD
- Recruiting
UZ Brussel
Brussels, 1090
Stijn Lochy, MD
- Recruiting
Cliniques Universitaires Saint-Luc UCL
Brussels
Joelle Kefer, MD
- Not yet recruiting
Centre hospitalier universitaire CHU de Liège
Liège
Patrizio Lancellotti, MD
- Recruiting
AZ Delta
Roeselare, 8800
Maarten Vanhaverbeke, MD
Germany2 sites, 2 recruiting
- Not yet recruiting
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, 55131
Phiipp Lurz, MD
- Recruiting
Ludwig Maximilian University Hospital
Munich, 81377
Jörg Hausleiter, MD
About this study
Official title: The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Read the detailed description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
- Being tested
- Transcatheter Tricuspid Valve Replacement
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve ReplacementDevice
Also called TRiCares Topaz Tricuspid Valve Replacement System
Replacement of the tricuspid valve through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Tricuspid Valve Replacement | Experimental | Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System Receives: Device: Transcatheter Tricuspid Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of MAE
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Measured: 30 day post-intervention
Investigational Device Success
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
Measured: immediately post-intervention
Secondary outcomes (3)
Six minute walk test
Change in distance (m) compared to baseline assessment
Measured: 30 days, 6 months, annual for five years post-intervention
Reduction in Tricuspid Regurgitation (TR) Grade
Number of patients presenting with reduction in TR grade compared to baseline assessment
Measured: 30 days, 6 months, annual for five years post-intervention
New York Heart Association (NYHA) Function Class
Number of patients presenting with improvement in NYHA classification
Measured: 30 days, 6 months, annual for five years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start29 Aug 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRiCares
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Hausleiter, MD, Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581471
- Sponsor's protocol ID
- 2401
- Acronym
- TRICURE EU
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
- ClinicalTrials.gov ID
- NCT06581471
- Acronym / sponsor ID
- TRICURE EU / 2401
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TRiCaresIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Sep 2024 (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.
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Detailed description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Tricuspid Valve Replacement | Experimental | Device: Transcatheter Tricuspid Valve ReplacementTreatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
- Institutional Heart Team evaluates patient as being at increased operative risk
Key exclusion criteria (4 listed)
- Patient in need of emergent intervention
- Patient who is hemodynamically unstable
- Anatomical contraindications for implantation with study device
- Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
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 |
|---|---|---|
| Transcatheter Tricuspid Valve ReplacementAlso: TRiCares Topaz Tricuspid Valve Replacement SystemReplacement of the tricuspid valve through a transcatheter approach | Device | Transcatheter Tricuspid Valve Replacement |
Primary outcome
Composite of MAE
Time frame: 30 day post-intervention
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Investigational Device Success
Time frame: immediately post-intervention
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
3 secondary outcomes
Six minute walk test
Time frame: 30 days, 6 months, annual for five years post-intervention
Reduction in Tricuspid Regurgitation (TR) Grade
Time frame: 30 days, 6 months, annual for five years post-intervention
New York Heart Association (NYHA) Function Class
Time frame: 30 days, 6 months, annual for five years post-intervention
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 15 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Valve Regurgitation
Active, not recruiting
TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Recruiting
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
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
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)
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.
Jörg Hausleiter, MD principal investigator
LMU Munich
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Valve Regurgitation and Heart Valve Disease, run by TRiCares at 8 sites in 2 countries.
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 4 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Germany. 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 Esther Gerteis (+41796015318, gerteis@tricares.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of MAE (time frame: 30 day post-intervention). 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 15 Apr 2026.