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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undegoing AF ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ischaemic lesion | ischemic lesion on MRI | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive evaluation | Change in the MoCA test result | one day before the procedure (the first MoCA test) and up to 1 year after the procedure (the second MoCA test) |
| NIHSS score | 24-36 hours after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a common clinical indication for AF ablation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktor Laskov, MD | Contact | +420267 161 111 | viktor.laskov@fnkv.cz |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41575412 | Derived | Laskov V, Hozman M, Malikova H, Lauer D, Kremenova K, Herman D, Hassouna S, Hornof J, Filipcova V, Vesela J, Waldauf P, Michalovova M, Karch J, Poviser L, Osmancik P. Cerebrovascular Ischemic Lesions After Pulsed Field Ablation for Atrial Fibrillation Using Variable-Loop Ablation Catheter. JACC Clin Electrophysiol. 2026 Apr;12(4):814-823. doi: 10.1016/j.jacep.2025.12.018. Epub 2026 Jan 22. |
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