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

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, 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

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: ( ClinicalTrials.gov ID: NCT03401099 ).

Keywords: Ablation; Atrial fibrillation; Atrial flutter; Cavo-tricuspid isthmus; Cryoballoon; Radiofrequency.

Conflict of interest statement

WYD, EW, LT, MT, GH, CM, KR, MB, IPT, ZC, RB, CR, NC and SM have no relevant disclosures to declare. MD has received fellowship funding from Biosense and speaker fees from Boston-Scientific. For work outside the submitted study, TR has received research grants from the Goldschmidt-Jacobson Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation, the European Union (Eurostars 9799–ALVALE), the Professor Max Cloëtta Foundation, the Cardiovascular Research Foundation Basel, the University of Basel and the University Hospital Basel; speaker/consulting honoraria or travel support from Abbott/SJM, Astra Zeneca, Brahms, Bayer, Biosense-Webster, Biotronik, Boston-Scientific, Daiichi Sankyo, Medtronic, Pfizer-BMS and Roche; and support for his institution’s fellowship programme from Abbott/SJM, Biosense-Webster, Biotronik, Boston-Scientific and Medtronic. CS reports grants and lecture fees from Biosense Webster and Medtronic and served as a proctor for Biosense Webster and Medtronic. DG is a speaker for Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Biosense Webster and Boston Scientific; proctor for Abbott and has received research grants from Medtronic, Biosense Webster and Boston Scientific.

Figures

Fig. 1
Fig. 1
Study flowchart for CRAFT

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