Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
University of Zagreb
150 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- paroxysmal atrial fibrillation
- patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
Exclusion Criteria1
- unwilling to sing the informed consent Left atrium size \> 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Interventions
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06183879