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

NCT05577078 | Not Yet Recruiting

• 1 other identifier: TriBEL
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Tricuspid Valve Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• 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 1 year post-procedure

  1 year

• 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 3 years post-procedure

  3 years

• Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure

  4 years

Study Arms (1)

TEER

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

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

Interventions

Transcatheter edge-to-edge repair (TEER) PROCEDURE

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

TEER

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Unwilling to provide informed consent

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 13, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 13, 2022

Record last verified: 2022-10