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

Recruiting · NCT07580547 · Interventional (participants receive a specific treatment) · Lead sponsor: Anat Milman

View the official record on ClinicalTrials.gov →

Interventions studied

Identifying extra-PV SRG sites

What this trial is about

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.

Who can take part

Age range

18 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Shamir Medical Center - Be’er Ya‘aqov, Israel

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →