Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
Rationale: Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty. Objectives: To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background. Study design: Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed. Study population: Patients aged 18 years and older with documented AF, scheduled for AF ablation. Main study endpoints: Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.

Official Title
-----------------
Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study

Conditions
-----------------
Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent

Intervention / Treatment
-----------------
* Procedure: Pulmonary vein isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older; Documented atrial fibrillation; Scheduled for AF ablation or redo AF ablation; Able and willing to provide written informed consent. Exclusion criteria Serious patient condition before ablation; Physically or mentally unable to provide written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pulmonary vein isolation|Participation in this study does not influence the choice of ablation technique. Usually, cryoballoon ablation is chosen for patients with paroxysmal AF and no previous ablations. Radiofrequency ablation is often used for redo procedures or for patients with persistent AF. Hybrid ablations are most applied in persistent AF patients. However, physicians may deviate from these standard approaches for a variety of reasons, including personal experience or preference.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation success | Ablation success is defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted. Atrial arrhythmias are AF, atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on ECG or Holter monitoring. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence of AF or atrial arrhythmia after the blanking period |  | 24 months | 
| Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period. |  | 3 months | 
| Disease progression to persistent or permanent AF. |  | 24 months | 
| Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. |  | 12 months | 
| Use of antiarrhythmic drugs (AADs) one year after ablation. |  | 12 months | 
| Number of veins with pulmonary vein reconnection at redo procedure. |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Vein Isolation, Cryoballoon ablation, Radiofrequency ablation, Atrial fibrillation