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NCT Number: NCT07159685

Sex-Based Differences of LA: Impact on AF 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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teknon Medical center

Barcelona, 08022, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrial fibrillation ablation

Procedure

Atrial fibrillation ablation with RF, guided by navigation system

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centro Medico Teknon

Other

Registry information

Official study title

Sex-Based Differences of Left Atrium: Impact on Atrial Fibrillation Ablation.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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