Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

NCT06425822 | Recruiting

• 1 other identifier: EC-2023-281
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Atrial Remodeling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Incidence of atrial fibrillation during follow-up.

  12 months

• Incidence of myocardial infarction during follow-up

  12 months

• Incidence of stroke during follow-up

  12 months

Study Arms (1)

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

Interventions

Left atrial electroanatomical mapping DIAGNOSTIC_TEST

Left atrial electroanatomical mapping (substrate and functional mapping)

Left atrial mapping group in patients without atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Andrea Sarkozy, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Sarkozy, MD, PhD

CONTACT

0032 02476 3657; Andrea.Sarkozy@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 22, 2024
• Study Start: November 8, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

BE (1)