Spanish Registry of Cryoballoon Ablation — RECABA  

Atrial Fibrillation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT02785991
• Study type: Observational
• Source: Medtronic Bakken Research Center
• Status: Completed
• Start date: July 2016
• Completion date: April 14, 2021