Sex-Based Differences of LA: Impact on AF Ablation.
ConditionAtrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Medico Teknon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Consecutive patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Atrial fibrillation ablation
Procedure/SurgeryAtrial fibrillation ablation with RF, guided by navigation system
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: patients who underwent a first ablation procedure for paroxysmal or persistent atrial fibrillation1 intervention
Trial outcomes
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
Time frame
from the procedure to 12 months laterSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: