Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation

Launched by DANIEL RODRÍGUEZ MUÑOZ · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to guide a procedure called pulmonary vein isolation (PVI), which is used to treat atrial fibrillation (AF), a common heart rhythm problem. The study compares using just X-ray imaging (called fluoroscopy) versus using a special mapping system that creates detailed pictures of the heart’s electrical activity to help guide the treatment. The goal is to see if adding this mapping system makes the procedure work better or if using X-ray alone is just as effective.

Adults diagnosed with either paroxysmal (occasional) or persistent atrial fibrillation who need PVI treatment may be eligible to join. People who have had this procedure before, have serious health issues, or certain other heart conditions won’t qualify. If you take part, you’ll undergo the PVI procedure using one of the two guidance methods being studied. This trial is currently recruiting participants, and it aims to find the best way to perform PVI that is safe and effective in treating atrial fibrillation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years old Diagnosed with paroxysmal or persistent AF Clinical indication to undergo PVI
• Exclusion Criteria:
• • Prior PVI or left atrial linear ablation Severe frailty or life expectancy \<1 year Unwillingness or inability to provide informed consent Ablation at sites beyond PVI or indication for additional electrophysiological study Contraindication or intolerance to heparin Presence of left atrial thrombus Congenital heart disease Pregnancy, ongoing or planned in the following 6 months