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Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

ConditionAtrial Remodeling
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of thrombus in the left atrial appendage.

Complications related to the index procedure.

Insufficient quality of the left atrial electroanatomical map.

Trial population

Consecutive patients undergoing ventricular arrhythmias ablations in whom transeptal access is needed for the ablation of the targeted arrhythmia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Left atrial electroanatomical mapping

    Diagnostic test

    Left atrial electroanatomical mapping (substrate and functional mapping)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Left atrial mapping group in patients without atrial fibrillation1 intervention

Trial outcomes

Primary outcomes

1

Substrate characterization of the left atrium.

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).

Time frame
18 months
2

Functional characterization of the left atrium.

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).

Time frame
18 months

Secondary outcomes

Other outcomes

1

Incidence of atrial fibrillation during follow-up.

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.

Time frame
12 months
2

Incidence of myocardial infarction during follow-up

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

Time frame
12 months
3

Incidence of stroke during follow-up

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.

Time frame
12 months
4

Incidence of transient ischemic attack incidence during follow-up

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

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitair Ziekenhuis Brussel

Lead sponsor

Source ClinicalTrials.gov
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