Atrial Fibrillation (AF)NCT07580547
Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes
A study testing Identifying extra-PV SRG sites in people with Atrial Fibrillation (AF), run by Anat Milman at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Identifying extra-PV SRG sites
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 5 May 2026to 19 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ofir Mitz contact
Israel1 site, 1 recruiting
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov
Anat Milman, MD, +972-54-3166651, anatmi@shamir.gov.il
Ofir Mitz, ofirm@shamir.gov.il
About this study
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)
- Being tested
- Identifying extra-PV SRG sites
- Keywords
- Ablation, Atrial Fibrillation, Gender, Sex, Disparity
- Medical subject headings
- Atrial Fibrillation, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identifying extra-PV SRG sitesDevice
After performing PVI as standard of care, mapping of both atria will be performed to locate extra-PV SRG sites.
| Study group | Role | What they receive |
|---|---|---|
| PVI ablation and identifying extra-PV SRG sites | Other | Men and women undergoing first time PVI ablation for identification of extra-PV SRG sites. Receives: Device: Identifying extra-PV SRG sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: During 12 month follow up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 May 2026
- Primary completion19 Apr 2027 (estimated)
- Study completion19 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anat Milman
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Anat Milman, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580547
- Sponsor's protocol ID
- DISPARITY-AF
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-Based Disparities in the Electrophysiological Substrate for Atrial Fibrillation and Its Impact on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07580547
- Acronym / sponsor ID
- DISPARITY-AF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Ablation, Atrial Fibrillation, Gender, Sex, Disparity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anat MilmanOther government
- Study start
- 5 May 2026 (actual)
- Primary completion
- 19 Apr 2027 (estimated)
- Study completion
- 19 Apr 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PVI ablation and identifying extra-PV SRG sites | Other | Device: Identifying extra-PV SRG sitesMen and women undergoing first time PVI ablation for identification of extra-PV SRG sites. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identifying extra-PV SRG sitesAfter performing PVI as standard of care, mapping of both atria will be performed to locate extra-PV SRG sites. | Device | PVI ablation and identifying extra-PV SRG sites |
Primary outcome
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)
1 secondary outcome
Freedom from AF and AT at one year.
Time frame: During 12 month follow up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ofir Mitz contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identifying extra-PV SRG sites in people with Atrial Fibrillation (AF), run by Anat Milman at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anat Milman, MD (+972-54-3166651, anatmi@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial distribution and frequency of extra-PV sites and AF initiation sites in both atria following standard PVI. (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.