A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).
An observational study evaluating the incidence of ischaemic lesions on brain MRI performed after ablation of atrial fibrillation using the Varipulse catheter. 1. A baseline MRI scan will be carried out one day before the procedure. 2. A post-procedure MRI scan will be performed 24-36 hours after the procedure. 3. A follow-up MRI will be performed within 1 year after the ablation. Paroxysmal and non-paroxysmal AF patients will be included. Regarding the extent of ablation lesions, pulmonary vein isolation (PVI) will be performed in paroxysmal AF, whereas PVI + left atrial posterior wall ablation will be performed in non-paroxysmal patients. All procedures will be performed under intracardiac echocardiography guidance. The patients will undergo a neurocognitive evaluation: 1. One day before the procedure: Montreal Cognitive Assessment (The MoCA Test) 2. 24-36 hours after the procedure: The National Institutes of Health Stroke Scale (NIHSS) 3. Up to 1 year after the procedure the MoCA test.
Study Type
OBSERVATIONAL
Enrollment
40
brain MRI scan: (1) one day before the procedure, (2) 24-36 hours after the procedure and (3) up to 1 year after the procedure
ischaemic lesion
ischemic lesion on MRI
Time frame: one day before the procedure (the first MRI scan), 24-36 hour sfter the procedure (the second scan) and up to 1 year after the procedure (the third scan)
Neurocognitive evaluation
Change in the MoCA test result
Time frame: one day before the procedure (the first MoCA test) and up to 1 year after the procedure (the second MoCA test)
NIHSS score
Time frame: 24-36 hours after the procedure
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