Tricuspid RegurgitationTRICURENCT05126030
The TRICURE First in Human Trial
A study testing Topaz TTVR System in people with Tricuspid Regurgitation, run by TRiCares at 11 sites in 2 countries.
Trial summary
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Topaz TTVR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 15 Jul 2022to 15 May 2029
- 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
- Subject of age >18 years.
- Subject with severe symptomatic tricuspid regurgitation presenting following conditions:
- TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
- symptoms requiring use of diuretics.
- Subject presenting with New York Heart Association Class NYHA ≥II.
- Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.
Who cannot join
- Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
- Subject undergoing cardiac interventions within 30 days prior to index procedure.
- Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
- Subject who had previous tricuspid valve replacement or repair and a device is still in situ.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France7 sites
CHU Bordeaux
Bordeaux, 33000
Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel
Bron, 69677
CHU Henri Mondor
Créteil, 94010
University Hospital Lille, Institut Cœur Poumon
Lille, 59037
Hôpital Saint Joseph
Marseille, 13008
CHU Pontchaillou
Rennes, 35000
Centre Cardiologique du Nord
Saint-Denis, 93200
Belgium4 sites
Algemeen Stedelijk Ziekenhuis,
Aalst
ZNA Middelheim
Antwerp
Cliniques Universitaires Saint-Luc UCL
Brussels, 1200
Centre hospitalier universitaire CHU de Liège
Liège
About this study
Official title: TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Read the detailed description
The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Topaz 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.
Topaz TTVR SystemDevice
Transcatheter tricuspid heart valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Experimental | Device: Topaz TTVR system Receives: Device: Topaz TTVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite endpoint
including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start15 Jul 2022
- Primary completion1 Mar 2025
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tricuspid 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
- Model description
- Topaz TTVR System
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRiCares
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Vanoverschelde, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de LouvainEmmanuel Teiger, MD, Principal investigator, CHU Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126030
- Sponsor's protocol ID
- 2101
- Acronym
- TRICURE
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teiger E, Nejjari M, Rosseel L, Kefer J, Verheye S, Lancellotti P, Oliver L, Obadia JF, Asch FM, Blanke P, Dreyfus J. TRICURE: first-in-human study of the Topaz transcatheter tricuspid heart valve system. EuroIntervention. 2025 Nov 14;21(22):1377-1385. doi: 10.4244/EIJ-D-25-00423.
PubMed 41243777
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial
- ClinicalTrials.gov ID
- NCT05126030
- Acronym / sponsor ID
- TRICURE / 2101
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TRiCaresIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 18 Nov 2021 (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 objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Detailed description
The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Topaz TTVR System
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | Experimental | Device: Topaz TTVR SystemDevice: Topaz TTVR system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject of age >18 years.
- Subject with severe symptomatic tricuspid regurgitation presenting following conditions:
- Subject presenting with New York Heart Association Class NYHA ≥II.
- Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.
Key exclusion criteria (4 listed)
- Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
- Subject undergoing cardiac interventions within 30 days prior to index procedure.
- Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
- Subject who had previous tricuspid valve replacement or repair and a device is still in situ.
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 |
|---|---|---|
| Topaz TTVR SystemTranscatheter tricuspid heart valve replacement | Device | Primary Cohort |
Primary outcome
Hierarchical composite endpoint
Time frame: 30 days
including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days
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 26 Mar 2025.
- Derived from this study: PubMed 41243777Teiger E, Nejjari M, Rosseel L, Kefer J, Verheye S, Lancellotti P, Oliver L, Obadia JF, Asch FM, Blanke P, Dreyfus J. TRICURE: first-in-human study of the Topaz transcatheter tricuspid heart valve system. EuroIntervention. 2025 Nov 14;21(22):1377-1385. doi: 10.4244/EIJ-D-25-00423.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Louis Vanoverschelde, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Emmanuel Teiger, MD principal investigator
CHU Henri Mondor
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topaz TTVR System in people with Tricuspid Regurgitation, run by TRiCares at 11 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 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05126030, which also lists 1 linked publication.
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 26 Mar 2025.