Substrate and trigger ablation for reduction of atrial fibrillation trial - Part II (STAR AF II): design and rationale

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dc.contributor.authorVerma, A.
dc.contributor.authorSanders, P.
dc.contributor.authorMacLe, L.
dc.contributor.authorDeisenhofer, I.
dc.contributor.authorMorillo, C.
dc.contributor.authorChen, J.
dc.contributor.authorJiang, C.
dc.contributor.authorErnst, S.
dc.contributor.authorMantovan, R.
dc.date.issued2012
dc.description.abstract<h4>Background</h4>The optimal ablation approach for patients with persistent atrial fibrillation (AF) remains unknown. In particular, it is unclear if pulmonary vein (PV) antral isolation (PVI) is sufficient as a lone strategy for persistent AF. Furthermore, if additional substrate ablation is to be added, the ideal approach to substrate ablation is yet to be determined.<h4>Objective</h4>The aim of this study is to determine the optimal strategy of catheter ablation of persistent AF by comparing the efficacy of 3 strategies: PVI vs PVI plus complex fractionated electrogram (CFE) ablation (PVI + CFE) vs PVI plus linear ablation (PVI + Lines).<h4>Study design</h4>The STAR AF II study (ClinicalTrials.gov NCT01203748) is a prospective, multicenter, randomized trial with a blinded assessment of outcomes. A total of 549 patients will be randomized in a 1:4:4 fashion to one of the investigation arms: PVI, PVI + CFE, and PVI + Lines, respectively. Patients undergoing a first-time ablation procedure for symptomatic, persistent AF that is refractory to at least 1 antiarrhythmic medication will be included. Persistent AF will be defined as a sustained episode lasting >7 days and <3 years. Patients with a left atrial parasternal size ≥60 mm will be excluded. The primary end point is freedom from documented AF >30 seconds at 18 months after 1 or 2 ablation procedures with or without antiarrhythmic medications.<h4>Conclusions</h4>The STAR AF II study is a randomized trial designed to evaluate the optimal approach for catheter ablation of persistent AF.
dc.description.statementofresponsibilityAtul Verma, Prashanthan Sanders, Laurent Macle, Isabel Deisenhofer, Carlos A. Morillo, Jian Chen, Chen-yang Jiang, Sabine Ernst and Roberto Mantovan
dc.identifier.citationAmerican Heart Journal, 2012; 164(1):1-12
dc.identifier.doi10.1016/j.ahj.2012.04.002
dc.identifier.issn0002-8703
dc.identifier.issn1097-6744
dc.identifier.orcidSanders, P. [0000-0003-3803-8429]
dc.identifier.urihttp://hdl.handle.net/2440/74027
dc.language.isoen
dc.publisherMosby Inc
dc.rights© 2012, Mosby, Inc. All rights reserved.
dc.source.urihttps://doi.org/10.1016/j.ahj.2012.04.002
dc.subjectHumans
dc.subjectAtrial Fibrillation
dc.subjectCatheter Ablation
dc.subjectProspective Studies
dc.subjectSingle-Blind Method
dc.subjectRandomized Controlled Trials as Topic
dc.titleSubstrate and trigger ablation for reduction of atrial fibrillation trial - Part II (STAR AF II): design and rationale
dc.typeJournal article
pubs.publication-statusPublished

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