Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF

Launched by YONSEI UNIVERSITY · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat a heart rhythm problem called paroxysmal atrial fibrillation (AF), which causes the heart to beat irregularly. The study compares two methods of using a special energy treatment, called pulsed field ablation (PFA), to isolate and calm the areas around the heart’s pulmonary veins that often cause AF. One method uses detailed heart images to guide the treatment based on the thickness of the heart wall, while the other uses a standard approach without this imaging. The goal is to see if the image-guided method helps reduce irregular heartbeats better than the standard method.

People who might be eligible for this study are adults between 19 and 80 years old who have paroxysmal AF that either keeps coming back despite medication or who cannot take certain heart rhythm medicines. They must have a left upper heart chamber (left atrium) that is not too large and need to be on blood thinners to prevent stroke. The study does not include people with long-lasting or permanent AF, serious heart or kidney problems, past heart surgeries, or other conditions that could make participation unsafe. If you take part, you will undergo one of the two PFA treatments during a planned procedure, and doctors will follow your heart rhythm afterward to see how well the treatment works. This study is not yet open for enrollment but may offer new insights into improving AF treatment in the future.

Gender

ALL

Eligibility criteria

• • Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥19 and ≤80 years of age
• • Left atrium size \< 50mm
• • paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
• • Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
• Exclusion Criteria:
• • Patients with persistent or permanent atrial fibrillation
• • Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
• • Patients with severe renal impairment or CT imaging difficulty using contrast media
• • Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
• • Patients with active internal bleeding
• • Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
• • Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
• • Patients with a severe comorbid disease
• • Expected survival \< 1 year
• • Drug addicts or alcoholics
• • Patients who cannot read the consent form (illiterates, foreigners, etc.)
• • Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study