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

Not yet recruiting

• Conditions: Tricuspid Valve Regurgitation
• Interventions: Procedure: Transcatheter edge-to-edge repair (TEER)

• Registration Number: NCT05577078
• Lead Sponsor: AZ Sint-Jan AV

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Study Start: 2023-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• Unwilling to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TEER	Transcatheter edge-to-edge repair (TEER)	Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER)

Primary Outcome Measures

Name	Time	Method
Number of patients with a reduction in tricuspid regurgitation score by at least one grade	30 days	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure
Composite of major adverse event	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 Outcome Measures

Name	Time	Method
Composite of major adverse event at discharge	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
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure	1 year	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure	3 years	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure	4 years	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure	5 years	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure	6 months	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure	2 years	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
Composite of major adverse event at 5 years post-procedure	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