Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

Atrial Remodeling Clinical Trial

— CLASS-VA  

Official title:

Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425822
• Other study ID #: EC-2023-281
• Status: Recruiting
• Start date: November 8, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: May 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Andrea Sarkozy, MD, PhD
• Phone: 0032 02476 3657
• Email: Andrea.Sarkozy[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Remodeling

Intervention

Diagnostic Test:
• Left atrial electroanatomical mapping
Left atrial electroanatomical mapping (substrate and functional mapping)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Incidence of myocardial infarction during follow-up	Only type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered.	12 months
Other	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
Other	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
Primary	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
Primary	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