title: Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design.
abstract: BACKGROUND
  Pulmonary vein antrum isolation (PVI) as a treatment of paroxysmal atrial fibrillation (AF) is associated with a high rate of success; however, outcomes for treating persistent and long-standing persistent AF with PVI alone are substantially lower and often require multiple procedures to maintain long-term freedom from atrial arrhythmias. Foci and/or substrate outside the pulmonary veins, particularly in the left atrial appendage (LAA), has been identified as a key mechanism in the maintenance of persistent AF and long-standing persistent AF.
  
  
  OBJECTIVE
  The goals of the study are to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the LAA and to determine if LAA ligation as adjunctive therapy to PVI improves maintenance of sinus rhythm in patients with persistent and long-standing persistent AF.
  
  
  METHODS
  The trial is a prospective, multicenter, randomized controlled study. The trial design incorporates a Bayesian adaptive design that will randomize a maximum of 600 patients with persistent or long-standing persistent AF to LAA ligation and PVI vs PVI alone in a 2:1 randomization. The primary end points include 30-day safety of the LARIAT procedure and freedom from documented AF, atrial flutter, or atrial tachycardia of more than 30 seconds at 12 months after the PVI off antiarrhythmic drugs. Key secondary outcomes include a composite of cardiovascular death and stroke, as well as quality of life.
  
  
  CONCLUSIONS
  The aMAZE trial will determine if LAA ligation as adjunctive therapy to PVI increases the efficacy of maintaining sinus rhythm in patients with persistent and long-standing persistent AF.
authors.affiliation: Section of Cardiac Electrophysiology, Division of Cardiology, Cardiovascular Research Institute at the University of California, San Francisco, San Francisco, CA. Electronic address: lee@medicine.ucsf.edu.
authors.forename: Randall J
authors.initials: RJ
authors.lastname: Lee
authors.affiliation: Division of Cardiology, University of Kansas Medical Center, Kansas City, KS.
authors.forename: Dhanunjaya
authors.initials: D
authors.lastname: Lakkireddy
authors.affiliation: Cardiac Electrophysiology Department, Valley Health System, New York, NY; Cardiac Electrophysiology Department, Valley Health System, Ridgewood, NJ.
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Vanderbilt Heart and Vascular Institute at Vanderbilt University, Nashville, TN.
authors.forename: Christopher
authors.initials: C
authors.lastname: Ellis
authors.affiliation: Berry Consultants, LLC, Austin, TX; University of Central Florida College of Medicine, Orlando, FL.
authors.forename: Jason T
authors.initials: JT
authors.lastname: Connor
authors.affiliation: Berry Consultants, LLC, Austin, TX; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN.
authors.forename: Benjamin R
authors.initials: BR
authors.lastname: Saville
authors.affiliation: Division of Cardiology, Loyola University Medical Center, Chicago, IL.
authors.forename: David
authors.initials: D
authors.lastname: Wilber
mesh_terms: D000328:Adult; D000368:Aged; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000523:psychology / Q000601:surgery; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011667:Pulmonary Veins / Q000601:surgery*; D011788:Quality of Life; D012107:Research Design; D020521:Stroke / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome