Observational Study on Silent Brain Lesions and Safety After Atrial Fibrillation Ablation Using the VARIPULSE Pulsed Field Ablation System

What this Trial Is About

Researchers are evaluating the occurrence and impact of silent cerebral lesions SCLs detected by brain MRI after pulsed field ablation PFA treatment for atrial fibrillation AF. This observational study focuses on adults with paroxysmal or persistent AF who undergo left-atrial ablation using the VARIPULSE PFA system, a new technique that uses electrical pulses to selectively target heart tissue while reducing harm to nearby areas. The study compares its findings with historical data from other ablation methods to understand neurological safety better. Participants will have brain MRI scans within 1 to 3 days after their PFA procedure to identify silent cerebral lesions. They will also complete neurological and cognitive tests assessing memory, language, and attention to detect any subtle changes. Routine clinical follow-up for AF management will continue as per standard care. This study does not include a control group but will analyze lesion characteristics such as number, size, and location on MRI. During the study, participants will undergo assessments from enrollment until three months after treatment. Researchers will measure the incidence of silent cerebral lesions and evaluate neurological complications, cognitive function, quality of life, and overall health status. The study aims to provide detailed MRI data and standardized evaluations to define the brain safety profile of PFA, supporting future improvements in AF ablation procedures.

A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation System