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NOT YET RECRUITING
NCT05577078

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

Sponsor: AZ Sint-Jan AV

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-01-01

Completion Date

2029-12-31

Last Updated

2022-10-13

Healthy Volunteers

No

Interventions

PROCEDURE

Transcatheter edge-to-edge repair (TEER)

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