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

Recruiting

• Conditions: Atrial Fibrillation Paroxysmal
• Interventions: Other: Standard of care; Other: Data collection

• Registration Number: NCT06085014
• Lead Sponsor: Centro Cardiologico Monzino

Brief 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.

Study Timeline

• Study Start: 2023-09-06
• Status Verified: 2023-10
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Standard of care	Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation
Retrospective cohort	Data collection	Patients who underwent ablative procedure in the two years prior to the start of the study

Primary Outcome Measures

Name	Time	Method
Assess clinical and electrophysiological predictors of arrhythmic recurrence	through study completion, an average of 1 year	Evaluate the role of atrial disease, assessed by baseline electroanatomic mapping, age, gender, echocardiographic data, years from first AF episode, in predicting AF recurrence after AF ablation.

Secondary Outcome Measures

Name	Time	Method
Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies	through study completion, an average of 1 year	Evaluate mid and long term efficacy, safety, procedural timing between Cryo ablation, Pulsed Field Ablation, Radio Frequency ablation, point by point or single shot ablation of paroxysmal atrial fibrillation.

Trial Locations

Locations (2)

Azienda Ospedaliera Universitaria delle Marche; 🇮🇹 Ancona, Italy

IRCCS Centro Cardiologico Monzino; 🇮🇹 Milan, Italy