Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05577078

TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique

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)

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old
  • Eligible for TEER procedure
  • Informed consent signed

Exclusion criteria

  • Unwilling to provide informed consent

Treatment and study plan

Transcatheter edge-to-edge repair (TEER)

Procedure

Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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 6 months post-procedure

  2. 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 1 year post-procedure

  3. 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 2 years post-procedure

  4. 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 3 years post-procedure

  5. 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 4 years post-procedure

  6. Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure

    Time frame: 5 years

    Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure

  7. Composite of major adverse event at discharge

    Time frame: 5 days

    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

  8. Composite of major adverse event at 5 years post-procedure

    Time frame: 5 years

    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

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Acronym: TriBEL

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Oct 13, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.