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

NCT ID: NCT05577078

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Tricuspid Valve Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TEER

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

Transcatheter edge-to-edge repair (TEER)

Intervention Type PROCEDURE

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

Interventions

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Transcatheter edge-to-edge repair (TEER)

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unwilling to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Jan Van der Heyden

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TriBEL

Identifier Type: -

Identifier Source: org_study_id

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