Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation

Charles University, Czech Republic

Status: Not yet enrolling

Conditions: Ischaemic Cerebral Infarction

Treatments: Diagnostic Test: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT06786988

CNS_MRI_PFA

Details and patient eligibility

About

A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AF with an indication for ablation

Exclusion criteria

• MRI contraindication

Trial design

40 participants in 1 patient group

Patients undegoing AF ablation

Treatment:

Diagnostic Test: MRI