TY - JOUR
T1 - Selective CFAE targeting for atrial fibrillation study (SELECT AF)
T2 - Clinical rationale, design, and implementation
AU - Verma, Atul
AU - Sanders, Prashanthan
AU - MacLe, Laurent
AU - Champagne, Jean
AU - Nair, Girish M.
AU - Calkins, Hugh
AU - Wilber, David J.
N1 - Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2011/5
Y1 - 2011/5
N2 - SELECT AF Methodology & Rationale. Background: Adjuvant ablation of complex fractionated atrial electrograms (CFAE) in addition to pulmonary vein isolation (PVI) likely improves procedural outcome compared to PVI alone, particularly in patients with persistent atrial fibrillation (AF). However, CFAE regions can be extensive, occasionally requiring a large amount of extra ablation. Some CFAE regions may also represent passive wavefront collision and may not require ablation. Thus, there is interest in identifying more selective CFAE sites that are critical to AF perpetuation, minimizing the amount of adjuvant ablation that must be performed. Objective: The SELECT AF study is a prospective, multicenter, randomized trial comparing a strategy of PVI plus generalized CFAE ablation versus a strategy of PVI plus selective CFAE ablation, focusing on regions of continuous electrical activity (CEA). The primary efficacy endpoint is freedom from atrial arrhythmia at 1 year and the primary safety endpoint is total radiofrequency (RF) delivery time per procedure. Methods: Patients undergoing a first time ablation procedure for symptomatic persistent AF will be included. Patients with permanent AF or with left atrial size ≥55 mm will be excluded. Patients will all receive PVI at the time of their ablation, but will be randomized 1:1 to receive adjuvant CFAE ablation using the traditional "generalized" approach, or a "selective" approach targeting only CEA regions. Both strategies will be guided by automated mapping algorithms. This study will enroll a minimum of 80 evaluable subjects; 40 in each randomization group. Conclusions: SELECT AF is a randomized trial in patients with persistent AF to evaluate the efficacy of selective versus generalized CFAE ablation in addition to traditional PVI. (J Cardiovasc Electrophysiol, Vol. 22, pp. 541-547 May 2011)
AB - SELECT AF Methodology & Rationale. Background: Adjuvant ablation of complex fractionated atrial electrograms (CFAE) in addition to pulmonary vein isolation (PVI) likely improves procedural outcome compared to PVI alone, particularly in patients with persistent atrial fibrillation (AF). However, CFAE regions can be extensive, occasionally requiring a large amount of extra ablation. Some CFAE regions may also represent passive wavefront collision and may not require ablation. Thus, there is interest in identifying more selective CFAE sites that are critical to AF perpetuation, minimizing the amount of adjuvant ablation that must be performed. Objective: The SELECT AF study is a prospective, multicenter, randomized trial comparing a strategy of PVI plus generalized CFAE ablation versus a strategy of PVI plus selective CFAE ablation, focusing on regions of continuous electrical activity (CEA). The primary efficacy endpoint is freedom from atrial arrhythmia at 1 year and the primary safety endpoint is total radiofrequency (RF) delivery time per procedure. Methods: Patients undergoing a first time ablation procedure for symptomatic persistent AF will be included. Patients with permanent AF or with left atrial size ≥55 mm will be excluded. Patients will all receive PVI at the time of their ablation, but will be randomized 1:1 to receive adjuvant CFAE ablation using the traditional "generalized" approach, or a "selective" approach targeting only CEA regions. Both strategies will be guided by automated mapping algorithms. This study will enroll a minimum of 80 evaluable subjects; 40 in each randomization group. Conclusions: SELECT AF is a randomized trial in patients with persistent AF to evaluate the efficacy of selective versus generalized CFAE ablation in addition to traditional PVI. (J Cardiovasc Electrophysiol, Vol. 22, pp. 541-547 May 2011)
KW - atrial fibrillation
KW - clinical trial
KW - complex fractionated atrial electrograms
KW - electroanatomical mapping
KW - left atrium
KW - radiofrequency ablation
UR - http://www.scopus.com/inward/record.url?scp=79955882553&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79955882553&partnerID=8YFLogxK
U2 - 10.1111/j.1540-8167.2010.01959.x
DO - 10.1111/j.1540-8167.2010.01959.x
M3 - Article
C2 - 21087332
AN - SCOPUS:79955882553
SN - 1045-3873
VL - 22
SP - 541
EP - 547
JO - Journal of cardiovascular electrophysiology
JF - Journal of cardiovascular electrophysiology
IS - 5
ER -