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

Lookup NU author(s): Dr Moloy Das

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2020, The Author(s). 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: (ClinicalTrials.gov ID: NCT03401099).

Publication metadata

Author(s): Ding WY, Williams E, Das M, Tovmassian L, Tayebjee M, Haywood G, Martin C, Rajappan K, Bates M, Temple IP, Reichlin T, Chen Z, Balasubramaniam R, Ronayne C, Clarkson N, Mahida S, Sticherling C, Gupta D

Publication type: Article

Publication status: Published

Journal: Journal of Interventional Cardiac Electrophysiology

Year: 2021

Volume: 60

Pages: 427-432

Print publication date: 01/04/2021

Online publication date: 08/05/2020

Acceptance date: 06/04/2020

Date deposited: 28/05/2020

ISSN (print): 1383-875X

ISSN (electronic): 1572-8595

Publisher: Springer

URL: https://doi.org/10.1007/s10840-020-00746-6

DOI: 10.1007/s10840-020-00746-6

PubMed id: 32385774

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