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 | Recruiting

• 1 other identifier: VARIACE study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

atrial fibrillation; catheter ablation; silent cerebral lesions; pulsed field ablation

Outcome Measures

Primary Outcomes (1)

• Incidence of silent cerebral lesions (SCLs)

  The proportion of patients in whom silent cerebral lesions (SCLs) are detected on brain MRI performed within 72 hours after atrial fibrillation ablation using the VARIPULSE PFA catheter. Definition of SCL: A lesion that shows positive findings on both diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (5)

• Number and total volume (mm³) of silent cerebral lesions (SCLs) in patients with positive SCL findings after the procedure.

  From enrollment to the end of treatment at 3 months

• Neurological complications

  From enrollment to the end of treatment at 3 months

• Cognitive function

  From enrollment to the end of treatment at 3 months

• Quality of Life (QoL)

  From enrollment to the end of treatment at 3 months

• General health status

  From enrollment to the end of treatment at 3 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is designed as a registry to evaluate safety without a control group. The target sample size was determined with reference to previous studies that assessed the incidence of silent cerebral lesions (SCLs) using post-procedural MRI, in which approximately 30 to 40 patients were typically included.

You may qualify if:

• \) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter

You may not qualify if:

• Individuals under 19 years of age
• Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
• Patients with a history of stroke or transient ischemic attack (TIA)
• Patients who have previously undergone ablation or surgery for atrial fibrillation
• Patients with intracardiac thrombus or embolic events within the past 90 days
• Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days
• Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade)
• Patients with a left ventricular ejection fraction (LVEF) of less than 35%
• Women who are currently pregnant or planning to become pregnant during the study period
• Patients with a life expectancy of less than one year
• Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)

Sponsors & Collaborators

• Biosense Webster, Inc.: collaborator
• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Universtiy Hospital, Seoul

Seoul, Jongro-ku, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eue-Keun Choi, MD, PhD

CONTACT

82-2-2072-0688; choiek417@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 23, 2026
• Study Start: December 26, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-10

Locations

KR (1)