NCT05577078

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
PROCEDURE	Transcatheter edge-to-edge repair (TEER)	Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-31
• Completion: 2029-12-31
• First posted: 2022-10-13
• Last updated: 2022-10-13