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Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation

Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06786988
Enrollment
40
Registered
2025-01-22
Start date
2025-02-01
Completion date
2025-12-01
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic Cerebral Infarction

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

DIAGNOSTIC_TESTMRI

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

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* AF with an indication for ablation

Exclusion criteria

* MRI contraindication

Design outcomes

Primary

MeasureTime frameDescription
ischaemic lesionone 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

MeasureTime frameDescription
Neurocognitive evaluationone 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 score24-36 hours after the procedure

Contacts

Primary ContactViktor Laskov, MD
viktor.laskov@fnkv.cz+420267 161 111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026