Atrial Fibrillation (AF)
Conditions
Keywords
Ablation, Atrial Fibrillation, Gender, Sex, Disparity
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.
Interventions
DEVICEIdentifying extra-PV SRG sites
After performing PVI as standard of care, mapping of both atria will be performed to locate extra-PV SRG sites.
Sponsors
Anat Milman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spatial distribution and frequency of extra-PV sites and AF initiation sites in both atria following standard PVI. | During procedure | Number of extra-PV sites and AF initiations for every patient (N per patient) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from AF and AT at one year. | 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. |
Countries
Israel
Contacts
CONTACTAnat Milman, MD
CONTACTOfir Mitz
Outcome results
None listed