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Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06425822
Acronym
CLASS-VA
Enrollment
50
Registered
2024-05-22
Start date
2023-11-08
Completion date
2027-10-31
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Remodeling

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?

Interventions

DIAGNOSTIC_TESTLeft atrial electroanatomical mapping

Left atrial electroanatomical mapping (substrate and functional mapping)

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Substrate characterization of the left atrium.18 monthsSubstrate 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).
Functional characterization of the left atrium.18 monthsFunctional 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

MeasureTime frameDescription
Incidence of atrial fibrillation during follow-up.12 monthsEpisodes 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.
Incidence of myocardial infarction during follow-up12 monthsOnly type 1 myocardial infarctions, those related to acute coronary obstruction, will be considered.
Incidence of stroke during follow-up12 monthsStroke 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.
Incidence of transient ischemic attack incidence during follow-up12 monthsTransient ischemic attack will be defined as a sudden, focal neurological deficit of presumed vascular origin lasting less than 24 hours.

Countries

Belgium

Contacts

Primary ContactAndrea Sarkozy, MD, PhD
Andrea.Sarkozy@uzbrussel.be0032 02476 3657

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026