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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI ablation and identifying extra-PV SRG sites | Other | Men and women undergoing first time PVI ablation for identification of extra-PV SRG sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Identifying extra-PV SRG sites | Device | After performing PVI as standard of care, mapping of both atria will be performed to locate extra-PV SRG sites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spatial distribution and frequency of extra-PV sites and AF initiation sites in both atria following standard PVI. | Number of extra-PV sites and AF initiations for every patient (N per patient) | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF and AT at one year. | Number of patients with recurrence is defined as any documented AF, AT or atrial flutter lasting ≥30 seconds using ECG and holter monitoring. | During 12 month follow up period. |
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Inclusion Criteria:
Exclusion Criteria:
The study requires 50 male patients and 50 female patients.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anat Milman, MD | Contact | +972-54-3166651 | anatmi@shamir.gov.il | |
| Ofir Mitz | Contact | ofirm@shamir.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center | Recruiting | Be’er Ya‘aqov | Israel |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2026 | Apr 21, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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.
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |