Atrial Remodeling Clinical Trial
— CLASS-VAOfficial title:
Characterization of Left Atrial Substrate in Patients With Ventricular Arrhythmias
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?
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Jette | Brussels |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
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 |
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