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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

NCT07363278 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-26
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363278 on ClinicalTrials.gov