Atrial Fibrillation Paroxysmal
Conditions
Keywords
pulmonary vein isolation, atrial fibrillation, catheter ablation, electroanatomical map
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.
Interventions
OTHERStandard 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
OTHERData 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
Sponsors
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Centro Cardiologico Monzino
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactStefania Riva, MD
Backup ContactLorenzo Bianchini, MD
Outcome results
None listed