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Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
Sponsor: University of Zagreb
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-01-01
Completion Date
2026-01-01
Last Updated
2024-05-28
Healthy Volunteers
No
Conditions
Interventions
cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
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