NCT07580547 Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes
| NCT ID | NCT07580547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anat Milman |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2027-04-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-05-05 with a primary completion date of 2027-04-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 between 18 and 80 years. * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07580547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07580547 currently recruiting?
Yes, NCT07580547 is actively recruiting participants. Contact the research team at anatmi@shamir.gov.il for enrollment information.
Where is the NCT07580547 trial being conducted?
This trial is being conducted at Be’er Ya‘aqov, Israel.
Who is sponsoring the NCT07580547 clinical trial?
NCT07580547 is sponsored by Anat Milman. The trial plans to enroll 100 participants.
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