Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06425822

Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

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?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrial Remodeling Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location status: Recruiting

Location contact

Andrea Sarkozy, MD, PhD

CONTACT

[email protected]

0032 02476 3657

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Left atrial electroanatomical mapping

Diagnostic Test

Left atrial electroanatomical mapping (substrate and functional mapping)

Primary outcomes

  1. Substrate characterization of the left atrium.

    Time frame: 18 months

    Substrate characterization will involve measuring Low Voltage (LV) and Transition Voltage (TV) Zones (LV zone voltage cut-off of <0.5mV; TV zone voltage limits within 0.5 and 1mV). These zones will be considered if they encompass an area of at least 1cm², containing ≥3 neighboring points within ≤10mm distance. The total LVZ and TVZ surfaces will be expressed as a percentage relative to the total surface area of the left atrium (excluding the pulmonary veins and the mitral annulus).

    A comparative analysis of substrate characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation).

  2. Functional characterization of the left atrium.

    Time frame: 18 months

    Functional analysis will rely on identifying deceleration zones characterized by isochronal crowding, defined as having ≥3 isochrones within a 1cm radius, using an 8-color scale of left atrial isochronal activation mapping.

    A comparative analysis of functional characteristics will be conducted between two groups: the study group (comprising patients without atrial fibrillation but at risk of developing it) and the control group (a historical cohort of patients with known atrial fibrillation).

Other outcomes

  1. Incidence of atrial fibrillation during follow-up.

    Time frame: 12 months

    Episodes diagnosed via a single-lead ECG tracing or a complete 12-lead ECG lasting at least 30 seconds, or AHRE episodes detected by any cardiac implantable electronic device (CIED), lasting at least 5 minutes.

  2. Incidence of myocardial infarction during follow-up

    Time frame: 12 months

    Only type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered.

  3. Incidence of stroke during follow-up

    Time frame: 12 months

    Stroke will be defined as any objective evidence of permanent brain, spinal cord, or retinal cell death resulting from a vascular cause, substantiated by pathological or imaging evidence, with or without accompanying clinical symptoms.

  4. Incidence of transient ischemic attack incidence during follow-up

    Time frame: 12 months

    Transient ischemic attack will be defined as a sudden, focal neurological deficit of presumed vascular origin lasting less than 24 hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Sarkozy, MD, PhD

CONTACT

[email protected]

0032 02476 3657

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: CLASS-VA

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 22, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.