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.

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.

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.

The sample size will be approximately 1000 subjects who must be enrolled over the two-year period, based on the annual rate of cryoballoon ablations carried out in Spain.

Study Protocol

Adverse events were collected during enrollment and follow up phase, 32 months.

A total of 337 adverse events have been reported, from which 34 were classified as serious.

The 337 reported events correspond to 277 different subjects. 83% of reported events are pertaining to one single patient, 13.4% of subjects have more than one adverse event, 3.2% have 3 reported events and one patient (0.4%) had 6 reported adverse events.