Tricuspid Valve RegurgitationTriBELNCT05577078
TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
An observational study of Tricuspid Valve Regurgitation, run by AZ Sint-Jan AV.
Trial summary
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Tricuspid Valve Regurgitation
- What is being tested?
- Transcatheter edge-to-edge repair (TEER)
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair
Who may be able to join
- At least 18 years old
- Eligible for TEER procedure
- Informed consent signed
Who cannot join
- Unwilling to provide informed consent
About this study
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.
The main endpoints are:
- Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade
- Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
- Conditions
- Tricuspid Valve Regurgitation
- Being tested
- Transcatheter edge-to-edge repair (TEER)
- 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.
Transcatheter edge-to-edge repair (TEER)Procedure or surgery
Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation
| Study group | Role | What they receive |
|---|---|---|
| TEER | Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER) Receives: Procedure: Transcatheter edge-to-edge repair (TEER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a reduction in tricuspid regurgitation score by at least one grade
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure
Measured: 30 days
Composite of major adverse event
Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
Measured: 1 year
Secondary outcomes (8)
Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure
Measured: 6 months
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
Measured: 1 year
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
Measured: 2 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
Measured: 3 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure
Measured: 4 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure
Measured: 5 years
Composite of major adverse event at discharge
Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia) at discharge
Measured: 5 days
Composite of major adverse event at 5 years post-procedure
Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia) 5 years post-procedure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Van der Heyden, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577078
- Sponsor's protocol ID
- TriBEL
- Acronym
- TriBEL
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
- ClinicalTrials.gov ID
- NCT05577078
- Acronym / sponsor ID
- TriBEL / TriBEL
- Conditions
- Tricuspid Valve Regurgitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Oct 2022 (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.
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.
The main endpoints are:
- Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade
- Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEER | – | Procedure: Transcatheter edge-to-edge repair (TEER)Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair
Key inclusion criteria (3 listed)
- At least 18 years old
- Eligible for TEER procedure
- Informed consent signed
Key exclusion criteria (1 listed)
- Unwilling to provide informed consent
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 edge-to-edge repair (TEER)Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation | Procedure or surgery | TEER |
Primary outcome
Number of patients with a reduction in tricuspid regurgitation score by at least one grade
Time frame: 30 days
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure
Composite of major adverse event
Time frame: 1 year
Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
8 secondary outcomes
Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure
Time frame: 6 months
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
Time frame: 1 year
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
Time frame: 2 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
Time frame: 3 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure
Time frame: 4 years
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure
Time frame: 5 years
Composite of major adverse event at discharge
Time frame: 5 days
Composite of major adverse event at 5 years post-procedure
Time frame: 5 years
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 13 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Regurgitation, run by AZ Sint-Jan AV.
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 1 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: opening soon, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with a reduction in tricuspid regurgitation score by at least one grade (time frame: 30 days). 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 13 Oct 2022.