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Recruiting NCT06425822

Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

Observational Atrial Remodeling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Left atrial electroanatomical mapping.
Who it may be relevant to
Registry conditions: Atrial Remodeling. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a CHA2DS2-VASc score ≥ 2 points. The study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion. The main questions it aims to answer are: * Are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation? * Are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it? * What is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes?

Interventions

  • Diagnostic test Left atrial electroanatomical mapping
    Left atrial electroanatomical mapping (substrate and functional mapping)

Primary outcome measures

  • Substrate characterization of the left atrium. [Time frame: 18 months]
  • Functional characterization of the left atrium. [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

  • Absence of a prior history of atrial fibrillation or flutter.
  • Patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a CHA2DS2-VASc score ≥ 2.

Exclusion criteria

  • Presence of thrombus in the left atrial appendage.
  • Complications related to the index procedure.
  • Insufficient quality of the left atrial electroanatomical map.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Universitair Ziekenhuis Brussel — Jette

Identifiers

NCT: NCT06425822 · EC-2023-281

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗