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

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?

Study Overview

• Status: Recruiting
• Conditions: Atrial Remodeling
• Intervention / Treatment: Diagnostic test: Left atrial electroanatomical mapping

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Andrea Sarkozy, MD, PhD; Phone Number: 0032 02476 3657; Email: Andrea.Sarkozy@uzbrussel.be

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Andrea Sarkozy, MD, PhD; Phone Number: 0032 02476 3657; Email: Andrea.Sarkozy@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Left atrial mapping group in patients without atrial fibrillation; 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.

Diagnostic test: Left atrial electroanatomical mapping; Left atrial electroanatomical mapping (substrate and functional mapping)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	18 months
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).	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Incidence of myocardial infarction during follow-up	Only type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered.	12 months
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Andrea Sarkozy, MD, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Atrial Remodeling
• Other Study ID Numbers: EC-2023-281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No