Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial—Part II (STAR AF II): Design and Rationale - 13/07/12

Doi : 10.1016/j.ahj.2012.04.002

Atul Verma, MD ^a,^{^⁎}, Prashanthan Sanders, MBBS, PhD ^b, Laurent Macle, MD ^c, Isabel Deisenhofer, MD ^d, Carlos A. Morillo, MD ^e, Jian Chen, MD ^f, Chen-yang Jiang, MD ^g, Sabine Ernst, MD ^h, Roberto Mantovan, MD ⁱ
^a Southlake Regional Health Centre, Newmarket, Ontario, Canada
^b Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia
^c Montreal Heart Institute, Montreal, Quebec, Canada
^d Deutsches Herzzentrum München, Munich, Germany
^e Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada
^f Haukeland University Hospital, University of Bergen, Bergen, Norway
^g Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, China
^h Royal Brompton Hospital, London, United Kingdom
ⁱ Ospedale S. Maria di Ca' Foncelli, Treviso, Italy

^⁎Reprint requests: Atul Verma, MD FRCPC, Southlake Regional Health Centre, 105-712 Davis Dr, Newmarket, Ontario, Canada L3Y 8C3.

Résumé

Background

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.

Objective

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).

Study Design

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.