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

NCT07159685 | Not Yet Recruiting

• 1 other identifier: Sex-Tailored By-LAWT AF
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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. Specifically, to compare anatomical characteristics, procedural parameters, and clinical outcomes between sexes.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• 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

  from the procedure to 12 months later

Study Arms (1)

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

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablation PROCEDURE

Atrial fibrillation ablation with RF, guided by navigation system

patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Teknon Medical center

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Electrophysiology Unit

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 8, 2025
• Study Start: January 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)