Actively Recruiting
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
Led by University of Zagreb · Updated on 2024-05-28
150
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of paroxysmal atrial fibrillation
- Scheduled for cryoballoon pulmonary vein isolation regardless of this study
You will not qualify if you...
- Unwilling to sign the informed consent
- Left atrium size greater than 55 mm
- Uncontrolled heart failure classified as NYHA III-IV
- Presence of intracardiac thrombi
AI-Screening
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Trial Site Locations
Total: 2 locations
1
KB Dubrava
Zagreb, Please Select, Croatia, 10000
Actively Recruiting
2
KBC Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
Research Team
V
Vedran Velagic, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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