Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Ischaemic Cerebral Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Diagnostic test MRI
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
Primary outcome measures
- ischaemic lesion [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)]
Secondary outcome measures (2)
- Neurocognitive evaluation [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]
Eligibility criteria
Inclusion criteria
- AF with an indication for ablation
Exclusion criteria
- MRI contraindication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 41575412
Identifiers
NCT: NCT06786988 · CNS_MRI_PFA