Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design.

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. STUDY DESIGN: 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. CONCLUSION: 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.