NCT07363278

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Study Type: Observational Study Goal: The goal of this study is to evaluate the incidence and burden of silent cerebral lesions (SCLs) detected on brain magnetic resonance imaging (MRI) after pulsed field ablation (PFA) for atrial fibrillation (AF). PFA is a new non-thermal ablation technique that selectively targets cardiac tissue while minimizing damage to surrounding structures. The study focuses on adult patients with paroxysmal or persistent AF who undergo left-atrial ablation using the VARIPULSE PFA system.

Detailed description

Main Questions the Study Aims to Answer: What percentage of patients develop silent cerebral lesions after PFA using the VARIPULSE system? What are the lesion characteristics (number, size, and location) and total lesion burden on MRI? Are there any early neurological or cognitive changes related to these MRI findings? Comparison: This is an observational, single-arm study with no active control group. However, the findings will be compared with historical data from previous studies of thermal ablation (radiofrequency and cryoballoon) to explore potential differences in neurological safety. Participant Activities: Participants in this study will: Undergo brain MRI (DWI and FLAIR sequences) within 1-3 days after PFA to detect any silent cerebral lesions. Complete neurological and cognitive assessments (for example, tests of memory, language, and attention) to identify subtle functional changes. Receive routine clinical follow-up for AF management according to institutional standard of care. Background: Silent cerebral lesions are small ischemic brain injuries seen on MRI that cause no immediate symptoms but have been linked to later cognitive decline and increased risk of clinical stroke. They are known to occur in 10-40 % of patients after conventional AF ablation using radiofrequency or cryoballoon energy. Because PFA employs electrical pulses rather than heat, its effects on cerebral safety may differ. The VARIPULSE system integrates a variable-loop, multipolar PFA catheter with a three-dimensional electro-anatomical mapping system to improve procedural precision and reduce risk. Significance: As PFA use expands in clinical practice, understanding its neurological safety is crucial. This study will provide quantitative MRI data and standardized neurological evaluations to define the cerebral safety profile of PFA. The results are expected to inform procedural optimization and help establish evidence-based strategies for safer AF ablation.

Conditions

• Atrial Fibrillation (AF)

Timeline

• Start date: 2025-12-26
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: South Korea