NCT06085014

Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation

Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal Atrial Fibrillation Undergoing First Transcatheter Ablation Procedure of Atrial Fibrillation by Pulmonary Vein Isolation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

From the literature, the success rate (i.e., absence of AF recurrence) of ablation in cases of paroxysmal AF at one year changes between 70 and 85 percent. This rate is considered suboptimal. Currently there are no data that can assess which factors are predictive of recurrence both clinically and electrophysiologically. In particular, it is not known whether and to what extent the atrial substrate present under baseline conditions affects the success rate of the procedure and what relationships exist with other predictors such as age, sex, atrial size at echo, and duration of arrhythmia.

Detailed description

This is a multicenter prospective and retrospective observational study aimed at examining the role of the left atrial substrate and other baseline clinical variables on the efficacy of transcatheter ablation in patients with paroxysmal atrial fibrillation (AF) who underwent pulmonary vein isolation regardless of the power source and balloon or "point by point" catheters used. The study will evaluate whether there are baseline clinical or electrophysiological features that can predict the success of transcatheter atrial fibrillation ablation even before it is performed, so as to assess which patients may actually benefit, and which patients should instead undergo more extensive ablative procedures in conjunction with pulmonary vein isolation to achieve an optimal success rate.

Conditions

• Atrial Fibrillation Paroxysmal

Interventions

Type	Name	Description
OTHER	Standard of care	All patients will undergo, as clinically indicated, AF ablation by pulmonary vein isolation achievable by radiofrequency, cryoenergy, or electroporation. All patients will preliminarily undergo electroanatomic mapping of the atrium by CARTO/Navx/Rhythmia system indifferently. Patients will be given follow-up visits at 3-6-12 months, during which any arrhythmic recurrences will be assessed
OTHER	Data collection	There's no patient involvement. Data of patients who underwent ablative procedures two years before the start of the study will be retrospectively analyzed

Timeline

• Start date: 2023-09-06
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-10-16
• Last updated: 2023-10-16

Locations

2 sites across 1 country: Italy