Spanish Registry of Cryoballoon Ablation

Study Overview
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Brief Summary
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The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.

Detailed Description
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With this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent AF at Spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation. Secondary objectives are also defined as: Description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.). To evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure. Description of the complications related to the procedure. To evaluate the use of healthcare resources which this cryoablation procedure entails.

Official Title
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Prospective Observational Study of Pulmonary Vein Cryoablation in Subjects With Atrial Fibrillation (AF) in Spain

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Balloon cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signature of the Data Release Form Subjects ≥ 18 years old Subjects who meet the indication for the Cryoballoon Ablation procedure. Exclusion Criteria: Subjects with a life expectancy of less than 12 months. Subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.). Subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study. Co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Balloon cryoablation|pulmonary vein cryoablation for atrial fibrillation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. | Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Acute Efficacy of the Procedure: | Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure. | 24-48h | 
| Number of Adverse Events Related to the Procedure | The outcome measure is the number of Adverse Events Related to the Procedure | Up 30 days post procedure |