Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation
NCT ID: NCT06786988
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-02-01
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients undegoing AF ablation
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Responsible Party
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Marek Hozman, MD, PhD
Interventional electrophysiologist
Central Contacts
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Other Identifiers
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CNS_MRI_PFA
Identifier Type: -
Identifier Source: org_study_id
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