Clinical Trial

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

Recruiting
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Record status
This record was last updated September 11, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-05.
Trial Details
NCT Number NCT07118046
Lead Sponsor Daniel Rodríguez Muñoz
Conditions Atrial Fibrillation
Enrollment 96 participants
Start Date 2025-08-05
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-11