Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II): design and rationale

Atul Verma; Prashanthan Sanders; Laurent Macle; Isabel Deisenhofer; Carlos A Morillo; Jian Chen; Chen-yang Jiang; Sabine Ernst; Roberto Mantovan

doi:10.1016/j.ahj.2012.04.002

Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II): design and rationale

Am Heart J. 2012 Jul;164(1):1-6.e6. doi: 10.1016/j.ahj.2012.04.002.

Authors

Atul Verma¹, Prashanthan Sanders, Laurent Macle, Isabel Deisenhofer, Carlos A Morillo, Jian Chen, Chen-yang Jiang, Sabine Ernst, Roberto Mantovan

Affiliation

¹ Southlake Regional Health Centre, Newmarket, Ontario, Canada.

PMID: 22795275
DOI: 10.1016/j.ahj.2012.04.002

Abstract

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.

Conclusions: The STAR AF II study is a randomized trial designed to evaluate the optimal approach for catheter ablation of persistent AF.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial

MeSH terms

Atrial Fibrillation / surgery*
Catheter Ablation / methods*
Humans
Prospective Studies
Randomized Controlled Trials as Topic / methods
Single-Blind Method

Associated data

ClinicalTrials.gov/NCT01203748