Sex-Based Disparities in the Electrophysiological Substrate... | Clinical Trial | StuddyBuddy@endsection Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes
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Recruiting NCT07580547

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

Conditions: Atrial Fibrillation (AF)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Anat Milman

Location: Shamir Medical Center Be’er Ya‘aqov

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.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older. * Male or Female sex. * Symptomatic paroxysmal or persistent AF indicated for a first-time catheter ablation. * Ability to provide written informed consent. Exclusion Criteria: * Prior catheter ablation for AF or surgical MAZE. * Long-standing persistent AF (\>12 months). * Presence of intracardiac thrombus or contraindication to systemic anticoagulation. * Pregnant women and patients not able to provide an informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07580547). StuddyBuddy aggregates publicly available trial information.