Phase
Condition
Chest Pain
Arrhythmia
Atrial Fibrillation
Treatment
Cryoablation with cryoballoon 31 mm
Cryoablation with cryoballoon 28 mm
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age over 18 years old.
Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 yearsafter diagnosis.
Clinical indication to undergo a pulmonary vein isolation procedure using ballooncryoablation.
Exclusion
Exclusion Criteria:
Severe left atrial dilatation (indexed volume >48 ml/m2 or area >40 cm2 or indexeddiameter >3.0 cm/m2).
Previous endocardial or surgical ablation of atrial fibrillation.
Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy lessthan 1 year.
Inability to understand or give informed consent.
Performance of other left atrial ablations in addition to pulmonary veins.
Need to use another catheter in addition to the cryoablation catheter to completepulmonary vein isolation.
Contraindication to anticoagulation or intolerance to heparin.
Presence of intra-atrial thrombus.
Reversible cause of atrial fibrillation.
Severe mitral or aortic valve disease.
Congenital heart disease.
Pregnancy or the prospect of pregnancy in the next 12 months.
Study Design
Study Description
Connect with a study center
IRCCS Neuromed Mediterranean Neurological Institute
Pozzilli, Isernia
ItalySite Not Available
Casa di cura Villa dei Fiori
Acerra, Napoli
ItalySite Not Available
Poliambulanza Institute Hospital Foundation
Brescia,
ItalySite Not Available
Ospedale Santa Maria Goretti
Latina,
ItalySite Not Available
Clinica San Michele
Maddaloni,
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza,
ItalySite Not Available
Pellegrini Hospital
Napoli,
ItalySite Not Available
Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
Padova,
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
Rome,
ItalySite Not Available
S. Pietro Fatebenefratelli Hospital
Rome,
ItalySite Not Available
HU Basurto
Bilbao,
SpainSite Not Available
HU Virgen de las Nieves
Granada,
SpainSite Not Available
HU Juan Ramón Jiménez
Huelva,
SpainSite Not Available
HU Ramón y Cajal
Madrid,
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid,
SpainActive - Recruiting
HU Virgen de la Victoria
Málaga,
SpainSite Not Available
HU Virgen Macarena
Sevilla,
SpainSite Not Available
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