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

Recruiting now

Conditions studied: Atrial Fibrillation (AF)

In brief

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.

Key facts

Study ID: NCT07363278
Run by: Seoul National University Hospital
People needed: 40
Starts: 2025-12-26
Expected to finish: 2027-12-31
Last updated by the study team: 2026-01-23

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

Seoul National Universtiy Hospital, Seoul — Seoul, Jongro-ku, South Korea (enrolling)

Full record on ClinicalTrials.gov

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