Clinical trial NCT06085014: Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation Paroxysmal
Keywords: pulmonary vein isolation
atrial fibrillation
catheter ablation
electroanatomical map
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Ospedali Riuniti
First posted: 2023-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with paroxysmal AF with clinical indication to first transcatheter ablation procedure of AF by pulmonary vein isolation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess clinical and electrophysiological predictors of arrhythmic recurrence
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluate acute and mid- to long-term efficacy, safety, and procedural timing of different technologies
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliera Universitaria delle Marche
city: Milan
country: Italy
facility: IRCCS Centro Cardiologico Monzino
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino
name: Stefania Riva, MD
role: PRINCIPAL_INVESTIGATOR
References:
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