RecruitingNot ApplicableNCT07580547

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


Sponsor

Anat Milman

Enrollment

100 participants

Start Date

May 5, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Age 18 years or older.
  • Male or Female sex.
  • Symptomatic paroxysmal or persistent AF indicated for a first-time catheter ablation.
  • Ability to provide written informed consent.

Exclusion Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07580547


Related Trials