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


Ding, Wern Yew ORCID: 0000-0003-3596-6545, Williams, Emmanuel, Das, Moloy, Tovmassian, Lilith, Tayebjee, Muzahir, Haywood, Guy, Martin, Claire, Rajappan, Kim, Bates, Matthew, Temple, Ian Peter et al (show 8 more authors) (2021) Cryoballoon pulmonary vein isolation as first line treatment for typical atrial flutter (CRAFT): study protocol for a randomised controlled trial. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 60 (3). pp. 427-432.

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Abstract

<h4>Purpose</h4>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.<h4>Methods</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>( ClinicalTrials.gov ID: NCT03401099 ).

Item Type: Article
Uncontrolled Keywords: Atrial flutter, Cavo-tricuspid isthmus, Cryoballoon, Radiofrequency, Ablation, Atrial fibrillation
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 24 Jun 2021 08:42
Last Modified: 18 Jan 2023 21:37
DOI: 10.1007/s10840-020-00746-6
Open Access URL: https://doi.org/10.1007/s10840-020-00746-6
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3127537
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