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RECRUITINGINTERVENTIONAL

Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF). The main aims of the study are: * to compare the efficacy of two ablation devices (acute and 1 year success rates) * to compare the procedural characteristics (procedure duration, fluoroscopy duration, ablation time * to compare the complication rates Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon. Standard of care cryoballoon procedure will be performed alongside with standard postprocedural follow-up. • to compare the complication rates Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon.

Who May Be Eligible (Plain English)

Who May Qualify: - paroxysmal atrial fibrillation - patient scheduled for cryoballoon pulmonary vein isolation regardless of this study Who Should NOT Join This Trial: - unwilling to sing the willing to sign a consent form Left atrium size \> 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * paroxysmal atrial fibrillation * patient scheduled for cryoballoon pulmonary vein isolation regardless of this study Exclusion Criteria: * unwilling to sing the informed consent Left atrium size \> 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi

Treatments Being Tested

DEVICE

cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)

Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon

DEVICE

cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)

Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon

Locations (2)

KB Dubrava
Zagreb, Please Select, Croatia
KBC Zagreb
Zagreb, Croatia