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CRAFT

ClinicalTrials.gov Identifier: NCT03401099

Full Title

Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter

Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborator: Medtronic International Trading Sarl
Condition: Atrial Flutter Typical

Interventional Clinical Trial
Treatments:
Procedure: Radiofrequency ablation of CTI
Procedure: Cryoballoon PVI

Purpose
Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that recurrences of flutter and incidence of post-ablation atrial fibrillation are common.

In this study, the investigators asses the hypothesis that the use of cryoballoon Pulmonary Vein Isolation (‘novel’ treatment) to achieve the electrical disconnection between the pulmonary veins and the heart will lead to higher rates of freedom from abnormal heart rhythms (atrial flutter, atrial fibrillation, or atrial tachycardia) and more improved quality of life than treatment using heat energy (radiofrequency ablation) directed at the cavotricuspid isthmus (‘conventional treatment’).
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