← Back to Clinical Trials
Recruiting NCT07118046

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

Trial Parameters

Condition Atrial Fibrillation
Sponsor Daniel Rodríguez Muñoz
Study Type INTERVENTIONAL
Phase N/A
Enrollment 96
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-05
Completion 2025-12-30
Interventions
Pulmonary vein isolation

Brief Summary

We designed a study to evaluate the impact of a two systematic strategies for PVI with the octaspline, balloon-based PFA (B-PFA) catheter. We hypothesized that the addition of electroanatomic guidance is non-superior to fluoroscopy-only guidance in achieving durable PVI.

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

Related Trials