Ischaemic Cerebral Infarction
Conditions
Brief summary
A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).
Detailed description
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* AF with an indication for ablation
Exclusion criteria
* MRI contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ischaemic lesion | 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) | ischemic lesion on MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive evaluation | one day before the procedure (the first MoCA test) and up to 1 year after the procedure (the second MoCA test) | Change in the MoCA test result |
| NIHSS score | 24-36 hours after the procedure | — |