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

AZ Sint-Jan AV

Status: Not yet enrolling

Conditions: Tricuspid Valve Regurgitation

Treatments: Procedure: Transcatheter edge-to-edge repair (TEER)

Study type: Observational

Funder types: Other

Identifiers

NCT05577078

TriBEL

Details and patient eligibility

About

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)

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Unwilling to provide informed consent

Trial design

120 participants in 1 patient group

TEER

Description:

Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER)

Treatment:

Procedure: Transcatheter edge-to-edge repair (TEER)