Key result
The AD-Balloon study is an ongoing randomized trial designed to evaluate whether an additional 3-minute freezing cycle after pulmonary vein isolation reduces atrial tachyarrhythmia recurrence at 1 year in patients with paroxysmal atrial fibrillation.
Why the study?
Does an additional freezing cycle after pulmonary vein isolation reduce the occurrence of atrial tachyarrhythmias in patients with paroxysmal atrial fibrillation treated with cryoballoon ablation?
RCT (n=110)
1:1 ratio using Efron's biased coin design
Yes
Does an additional freezing cycle after pulmonary vein isolation reduce the occurrence of atrial tachyarrhythmias in patients with paroxysmal atrial fibrillation treated with cryoballoon ablation?
This study protocol outlines a randomized trial to determine if an additional 3-minute freezing cycle after pulmonary vein isolation improves 1-year freedom from atrial tachyarrhythmias in patients with paroxysmal atrial fibrillation undergoing cryoballoon ablation.
Additional freeze cycles after PVI confer no benefit; supports single-cycle CB2 protocol to shorten procedures without compromising outcomes.
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Miyamoto et al. (2016) conducted an RCT in Paroxysmal atrial fibrillation (n=110). Additional freezing cycle after pulmonary vein isolation vs. No additional freezing cycle was evaluated on Occurrence of atrial tachyarrhythmias at 1 year with a blanking period of 90 days. The AD-Balloon study is an ongoing randomized trial designed to evaluate whether an additional 3-minute freezing cycle after pulmonary vein isolation reduces atrial tachyarrhythmia recurrence at 1 year in patients with paroxysmal atrial fibrillation.
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