Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
1000

Summary

Conditions
Atrial Fibrillation
Type
Observational
Design
Observational Model: Case-OnlyTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 atri...

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.

Tracking Information

NCT #
NCT02785991
Collaborators
Medtronic
Investigators
Principal Investigator: Jesús Daniel Martínez Alday, MD Hospital de Basurto Principal Investigator: Ermengol Vallés, MD Hospital del Mar Principal Investigator: Rocío Cozar, MD Hospital Virgen del Rocío Principal Investigator: Angel Ferrero, MD Hospital Clínico de Valencia Principal Investigator: Arcadio García Alberola, MD Hospital Virgen de la Arrixaca