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

Tricuspid Valve Regurgitation Clinical Trial

— TriBEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05577078
• Other study ID #: TriBEL
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: October 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• At least 18 years old

• Eligible for TEER procedure

• Informed consent signed

Exclusion Criteria:

• Unwilling to provide informed consent

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Procedure:
• Transcatheter edge-to-edge repair (TEER)
Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a reduction in tricuspid regurgitation score by at least one grade	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure	30 days
Primary	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)	1 year
Secondary	Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure	6 months
Secondary	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 1 year post-procedure	1 year
Secondary	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure	Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure	2 years
Secondary	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 3 years post-procedure	3 years
Secondary	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 4 years post-procedure	4 years
Secondary	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 5 years post-procedure	5 years
Secondary	Composite of major adverse event at discharge	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	5 days
Secondary	Composite of major adverse event at 5 years post-procedure	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	5 years