Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Identifying extra-PV SRG sites.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Identifying extra-PV SRG sites
After performing PVI as standard of care, mapping of both atria will be performed to locate extra-PV SRG sites.
Primary outcome measures
- Spatial distribution and frequency of extra-PV sites and AF initiation sites in both atria following standard PVI. [Time frame: During procedure]
Secondary outcome measures (1)
- Freedom from AF and AT at one year. [Time frame: During 12 month follow up period.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Israel · 1 center
- Shamir Medical Center — Be’er Ya‘aqov
Identifiers
NCT: NCT07580547 · DISPARITY-AF