Atrial Fibrillation Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Contact Information
Primary
Anat Milman, MD
anatmi@shamir.gov.il
+972-54-3166651
Backup
Ofir Mitz
ofirm@shamir.gov.il
Time Frame
Start Date: 2026-05-05
Estimated Completion Date: 2028-04-19
Participants
Target number of participants: 100
Treatments
Other: PVI ablation and identifying extra-PV SRG sites
Men and women undergoing first time PVI ablation for identification of extra-PV SRG sites.
Related Therapeutic Areas
Sponsors
Leads: Anat Milman

This content was sourced from clinicaltrials.gov