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
Location: See location...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter
Locations
Other Locations
Republic of Korea
Seoul National Universtiy Hospital, Seoul
RECRUITING
Seoul
Contact Information
Primary
Eue-Keun Choi, MD, PhD
choiek417@gmail.com
82-2-2072-0688
Time Frame
Start Date: 2025-12-26
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital
Collaborators: Biosense Webster, Inc.