Clinical Trial

Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes

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Summary
DISPARITY-AF is a prospective, single-center, observational registry designed to characterize the sex-based disparities in the electrophysiological substrate driving Atrial Fibrillation (AF). While standard Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, women consistently experience lower long-term success rates. This study tests the hypothesis that women harbor a significantly higher burden of unmapped, extra-pulmonary vein (extra-PV) AF initiation sites compared to men. In 100 consecutive patients undergoing first-time PVI, comprehensive biatrial repolarization mapping will be performed using programmed electrical stimulation (PES) to measure the atrial effective refractory period (AERP) in multiple atrial sites immediately after successful PVI. All mapping systems and multielectrode catheters utilized in this study are clinically approved and used routinely in our center. Identified steep repolarization gradients (SRGs) and AF initiation sites will be documented but not ablated. Patients will undergo intensive 1-year clinical follow-up to test the secondary hypothesis that patients with untreated extra-PV SRG/AF initiation sites have a significantly higher rate of AF recurrence.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-04
Trial Details
NCT Number NCT07580547
Lead Sponsor Anat Milman
Conditions Atrial Fibrillation (AF)
Enrollment 100 participants
Start Date 2026-05-05
Primary Completion 2027-04-19 (estimated)
Study Completion 2028-04-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-14