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

NCT07580547 | Not Yet Recruiting

• 1 other identifier: DISPARITY-AF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Ablation; Atrial Fibrillation; Gender; Sex; Disparity

Outcome Measures

Primary Outcomes (1)

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

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

  During procedure

Secondary Outcomes (1)

• Freedom from AF and AT at one year.

  During 12 month follow up period.

Study Arms (1)

PVI ablation and identifying extra-PV SRG sites

OTHER

Men and women undergoing first time PVI ablation for identification of extra-PV SRG sites.

Device: Identifying extra-PV SRG sites

Interventions

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.

PVI ablation and identifying extra-PV SRG sites

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study requires 50 male patients and 50 female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anat Milman: lead

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation; Coitus

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Central Study Contacts

Anat Milman, MD

CONTACT

+972-54-3166651; anatmi@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist in Electrophysiology Unit

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: April 19, 2026
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): April 19, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

IL (1)