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

• Sponsor: AZ Sint-Jan AV (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05577078
• Collaborator: (none)
• Enrollment: 120
• Anticipated Duration (Months): 84

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Regurgitation	Procedure: Transcatheter edge-to-edge repair (TEER)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
TEER Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER)	Procedure: Transcatheter edge-to-edge repair (TEER); Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years old

• Eligible for TEER procedure

• Informed consent signed

Exclusion Criteria:

• Unwilling to provide informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AZ Sint-Jan AV

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Van der Heyden, Principal Investigator, AZ Sint-Jan AV
• ClinicalTrials.gov Identifier: NCT05577078
• Other Study ID Numbers: TriBEL
• First Posted: Oct 13, 2022
• Last Update Posted: Oct 13, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Oct 13, 2022