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

Verma, A.Sanders, P.MacLe, L.Deisenhofer, I.Morillo, C.Chen, J.Jiang, C.Ernst, S.Mantovan, R.2012-11-062012-11-062012American Heart Journal, 2012; 164(1):1-120002-87031097-6744http://hdl.handle.net/2440/74027<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.en© 2012, Mosby, Inc. All rights reserved.HumansAtrial FibrillationCatheter AblationProspective StudiesSingle-Blind MethodRandomized Controlled Trials as TopicSubstrate and trigger ablation for reduction of atrial fibrillation trial - Part II (STAR AF II): design and rationaleJournal article002012070910.1016/j.ahj.2012.04.0020003063669000012-s2.0-8486366312723850Sanders, P. [0000-0003-3803-8429]