Sex-Based Differences of LA: Impact on AF Ablation.

NCT ID: NCT07159685

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Atrial fibrillation ablation

Intervention Type PROCEDURE

Atrial fibrillation ablation with RF, guided by navigation system

Interventions

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Atrial fibrillation ablation

Atrial fibrillation ablation with RF, guided by navigation system

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Medico Teknon

OTHER

Sponsor Role lead

Responsible Party

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Antonio Berruezo, MD, PhD

Chief of Electrophysiology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Teknon Medical center

Barcelona, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Sex-Tailored By-LAWT AF

Identifier Type: -

Identifier Source: org_study_id

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