ClinicalTrials.gg
RecruitingNCT07580547Updated Oct 20, 2026

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

An interventional study of Identifying extra-PV SRG sites in Atrial Fibrillation (AF), sponsored by Anat Milman. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Anat Milman · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Updated Oct 20, 2026Study documents postedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Atrial Fibrillation (AF)

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Keywords

  • Ablation
  • Atrial Fibrillation
  • Gender
  • Sex
  • Disparity
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In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Anat Milman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Prior catheter ablation for AF or surgical MAZE.
  • Long-standing persistent AF (>12 months).
  • Presence of intracardiac thrombus or to systemic anticoagulation.
  • Pregnant women and patients not able to provide an
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    PVI ablation and identifying extra-PV SRG sites

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

    Device: Identifying extra-PV SRG sites

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.

06

What researchers measure

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)

    Time frame: During procedure

Secondary outcomes

  1. Freedom from AF and AT at one year.

    Number of patients with recurrence is defined as any documented AF, AT or atrial flutter lasting ≥30 seconds using ECG and holter monitoring.

    Time frame: During 12 month follow up period.

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Apr 2027, 11 months after the start.

Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 11 months is below that.

Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
May 12, 2026
StartActual
May 5, 2026
Primary completionEst.
Apr 19, 2027
CompletionEst.
Apr 19, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Documents
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Documents Study protocol ↗ updated
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07580547
Lead sponsor
Anat Milman
Responsible party
Anat Milman (Cardiologist in Electrophysiology Unit, Assaf-Harofeh Medical Center) — Sponsor-investigator
First posted
May 12, 2026
Start date
May 5, 2026
Primary completion
Apr 19, 2027 (estimated)
Completion
Apr 19, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Anat Milman, MD
Contact
anatmi@shamir.gov.il
+972-54-3166651
Ofir Mitz
Contact
ofirm@shamir.gov.il

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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