Shamir Medical Center
Be’er Ya‘aqov, Israel
Location status: Recruiting
NCT Number: NCT07580547
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Be’er Ya‘aqov, Israel
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After performing PVI as standard of care, mapping of both atria will be performed to locate extra-PV SRG sites.
Time frame: During procedure
Number of extra-PV sites and AF initiations for every patient (N per patient)
Time frame: During 12 month follow up period.
Number of patients with recurrence is defined as any documented AF, AT or atrial flutter lasting ≥30 seconds using ECG and holter monitoring.
Contact information is provided by the study sponsor or research team.
Anat Milman
Other Gov
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