Atrial Fibrillation (AF)NCT07159685
Sex-Based Differences of LA: Impact on AF Ablation.
An observational study of Atrial Fibrillation (AF), run by Centro Medico Teknon at 1 site in Spain.
Trial summary
The aim of the study is to assess sex-related differences in patients who underwent a first ablation procedure for paroxysmal or persistent AF, guided by the personalized ablation strategy of the BY-LAWT protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 30 May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation
Who may be able to join
- Patients who underwent a first ablation procedure for atrial fibrillation (paroxysmal or persistent).
- Availability of an adequate pre-procedural cardiac CT scan for LAWT, LAV and inFAT analysis.
- Availability of complete procedural data, including ablation index (AI) values recorded using the SmartTouch catheter (Biosense Webster).
- Availability of 12-month follow-up data for efficacy and safety endpoint evaluation.
- Ablation performed according to the by-LAWT protocol
Who cannot join
- Age < 18 years.
- Previous cardiac ablation (including AF ablation or other arrhythmias).
- Incomplete data regarding procedural parameters, or follow-up.
- Poor quality pre-procedural cardiac MDCT
- Ablation not performed according to the BY-LAWT protocol.
- Structural heart disease (e.g., dilated cardiomyopathy, valvular heart disease with surgical indication) that could substantially influence atrial dimensions or ablation response.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sex-Based Differences of Left Atrium: Impact on Atrial Fibrillation Ablation.
The aim of the study is to assess sex-related differences in patients who underwent a first ablation procedure for paroxysmal or persistent AF, guided by the personalized ablation strategy of the BY-LAWT protocol. Specifically, to compare anatomical characteristics, procedural parameters, and clinical outcomes between sexes.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Atrial fibrillation ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Atrial fibrillation ablation with RF, guided by navigation system
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation | patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation Receives: Procedure: Atrial fibrillation ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in AF freedom
The primary efficacy endpoint will be freedom from any atrial arrhythmia (AF, atrial tachycardia [AT], or atrial flutter [AFL]) at the 12-month follow-up. The following definitions apply
Measured: from the procedure to 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159685
- Sponsor's protocol ID
- Sex-Tailored By-LAWT AF
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-Based Differences of Left Atrium: Impact on Atrial Fibrillation Ablation.
- ClinicalTrials.gov ID
- NCT07159685
- Acronym / sponsor ID
- Sex-Tailored By-LAWT AF
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
The aim of the study is to assess sex-related differences in patients who underwent a first ablation procedure for paroxysmal or persistent AF, guided by the personalized ablation strategy of the BY-LAWT protocol. Specifically, to compare anatomical characteristics, procedural parameters, and clinical outcomes between sexes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation | – | Procedure: Atrial fibrillation ablationpatients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation
Key inclusion criteria (5 listed)
- Patients who underwent a first ablation procedure for atrial fibrillation (paroxysmal or persistent).
- Availability of an adequate pre-procedural cardiac CT scan for LAWT, LAV and inFAT analysis.
- Availability of complete procedural data, including ablation index (AI) values recorded using the SmartTouch catheter (Biosense Webster).
- Availability of 12-month follow-up data for efficacy and safety endpoint evaluation.
- Ablation performed according to the by-LAWT protocol
Key exclusion criteria (6 listed)
- Age < 18 years.
- Previous cardiac ablation (including AF ablation or other arrhythmias).
- Incomplete data regarding procedural parameters, or follow-up.
- Poor quality pre-procedural cardiac MDCT
- Ablation not performed according to the BY-LAWT protocol.
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 |
|---|---|---|
| Atrial fibrillation ablationAtrial fibrillation ablation with RF, guided by navigation system | Procedure or surgery | patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation |
Primary outcome
Efficacy in AF freedom
Time frame: from the procedure to 12 months later
The primary efficacy endpoint will be freedom from any atrial arrhythmia (AF, atrial tachycardia [AT], or atrial flutter [AFL]) at the 12-month follow-up. The following definitions apply
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Centro Medico Teknon at 1 site in Spain.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in AF freedom (time frame: from the procedure to 12 months later). 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 8 Sep 2025.