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NCT Number: NCT07580547

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Spatial distribution and frequency of extra-PV sites and AF initiation sites in both atria following standard PVI.

    Time frame: During procedure

    Number of extra-PV sites and AF initiations for every patient (N per patient)

Secondary outcomes

  1. Freedom from AF and AT at one year.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anat Milman, MD

CONTACT

[email protected]

+972-54-3166651

Ofir Mitz

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Anat Milman

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 12, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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