NCT07363278 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
| NCT ID | NCT07363278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Atrial Fibrillation (AF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-12-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter Exclusion Criteria: 1. Individuals under 19 years of age 2. Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure 3. Patients with a history of stroke or transient ischemic attack (TIA) 4. Patients who have previously undergone ablation or surgery for atrial fibrillation 5. Patients with intracardiac thrombus or embolic events within the past 90 days 6. Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days 7. Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade) 8. Patients with a left ventricular ejection fraction (LVEF) of less than 35% 9. Women who are currently pregnant or planning to become pregnant during the study period 10. Patients with a life expectancy of less than one year 11. Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07363278 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07363278 currently recruiting?
Yes, NCT07363278 is actively recruiting participants. Contact the research team at choiek417@gmail.com for enrollment information.
Where is the NCT07363278 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07363278 clinical trial?
NCT07363278 is sponsored by Seoul National University Hospital. The trial plans to enroll 40 participants.
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