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

Study acronym: TriBEL
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record status
This record was last updated October 13, 2022 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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)
Trial Details
NCT Number NCT05577078
Lead Sponsor AZ Sint-Jan AV
Conditions
(from sponsor)		 Tricuspid Valve Regurgitation
Related terms Tricuspid Valve Insufficiency
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov