NCT06786988

Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischaemic Cerebral Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-01-22
• Last updated: 2025-01-22