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08.05.2020 | MULTIMEDIA REPORT Open Access

Cryoballoon pulmonary vein isolation as first line treatment for typical atrial flutter (CRAFT): study protocol for a randomised controlled trial

Zeitschrift:
Journal of Interventional Cardiac Electrophysiology
Autoren:
Wern Yew Ding, Emmanuel Williams, Moloy Das, Lilith Tovmassian, Muzahir Tayebjee, Guy Haywood, Claire Martin, Kim Rajappan, Matthew Bates, Ian Peter Temple, Tobias Reichlin, Zhong Chen, Richard Balasubramaniam, Christina Ronayne, Nichola Clarkson, Saagar Mahida, Christian Sticherling, Dhiraj Gupta
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s10840-020-00746-6) contains supplementary material, which is available to authorized users.
Wern Yew Ding and Emmanuel Williams joint first authors

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Abstract

Purpose

Treatment of typical atrial flutter (AFL) with cavo-tricuspid isthmus (CTI) ablation is associated with a high occurrence rate of new onset atrial fibrillation (AF) during follow-up. There are data to support the addition of pulmonary vein isolation (PVI) to CTI ablation in patients with both AF and AFL, but the role of cryoballoon PVI only, with no CTI ablation, in AFL patients with no prior documentation of AF has not been studied.

Methods

CRAFT is an international, prospective, randomised, open with blinded assessment, multicentre superiority study comparing radiofrequency CTI ablation and cryoballoon PVI in patients with typical AFL. Participants with typical AFL are randomised in a 1:1 ratio to either treatment arm, with patients randomised to PVI not receiving CTI ablation. Post-procedural cardiac monitoring is performed using an implantable loop recorder. The primary endpoint is time to first recurrence of sustained symptomatic atrial arrhythmia. Key secondary endpoints include (1) total arrhythmia burden at 12 months, (2) time to first episode of AF lasting ≥ 2 min, (3) time to recurrence of AFL or AT and (4) procedural and fluoroscopy times. The primary safety endpoint is the composite of death, stroke/transient ischaemic attack, cardiac tamponade requiring drainage, atrio-oesophageal fistula, requirement for a permanent pacemaker, serious vascular complications requiring intervention or delaying discharge and persistent phrenic nerve palsy lasting > 24 h.

Conclusion

This study compares the outcomes of 2 different approaches to typical AFL—the conventional ‘substrate’-based strategy of radiofrequency CTI ablation versus a novel ‘trigger’-based strategy of cryoballoon PVI.

Trial registration

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