NCT02785991

Spanish Registry of Cryoballoon Ablation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,742 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Balloon cryoablation	pulmonary vein cryoablation for atrial fibrillation

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-04-01
• Completion: 2021-04-14
• First posted: 2016-05-30
• Last updated: 2025-03-14
• Results posted: 2022-03-15

Locations

28 sites across 1 country: Spain