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Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias (CLASS-VA)

U

Universitair Ziekenhuis Brussel

Status

Enrolling

Conditions

Atrial Remodeling

Treatments

Diagnostic Test: Left atrial electroanatomical mapping

Study type

Observational

Funder types

Other

Identifiers

NCT06425822
EC-2023-281

Details and patient eligibility

About

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?

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Left atrial mapping group in patients without atrial fibrillation
Description:
Inclusion criteria: * Age ≥ 18 years old. * 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.
Treatment:
Diagnostic Test: Left atrial electroanatomical mapping

Trial contacts and locations

1

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Central trial contact

Andrea Sarkozy, MD, PhD

Data sourced from clinicaltrials.gov

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