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

Centro Cardiologico Monzino

Status: Enrolling

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Other: Data collection; Other: Standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT06085014

CCM 1981

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with indication for AF ablation
• Adequate anticoagulation therapy according to CHADs VASC

Exclusion criteria

• patients who had already undergo an AF ablation procedure
• Presence of intracavitary thrombus
• Ejection fraction <35%
• Pregnancy
• Hematologic contraindications to ionizing radiation exposure
• Congenital heart diseases
• Cardiac Surgery < 1month
• Uncontrolled heart failure
• Valvular disease
• Contraindications to general anesthesia

Trial design

300 participants in 2 patient groups

Prospective cohort

Description:

Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation

Treatment:

Other: Standard of care

Retrospective cohort

Description:

Patients who underwent ablative procedure in the two years prior to the start of the study

Treatment:

Other: Data collection