NCT07363278Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 29 Dec 2025
- Start date
- 26 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07363278
What you commit to
- Study type: Observational
- Planned participants: 40
- From 26 Dec 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
- Patients who have previously undergone ablation or surgery for atrial fibrillation
- Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)
Other illness
- Patients with a history of stroke or transient ischemic attack (TIA)
- 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)
Lab values
- Patients with a left ventricular ejection fraction (LVEF) of less than 35%
Age
- Individuals under 19 years of age
Other
- Patients with intracardiac thrombus or embolic events within the past 90 days
- Women who are currently pregnant or planning to become pregnant during the study period
- Patients with a life expectancy of less than one year
Who the study is looking for
- 1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National Universtiy Hospital, Seoul Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.