title: Study design of the man and machine trial: a prospective international controlled noninferiority trial comparing manual with robotic catheter ablation for treatment of atrial fibrillation.
abstract: BACKGROUND
  Pulmonary vein isolation (PVI) has become the cornerstone procedure for the treatment of symptomatic drug-resistant atrial fibrillation (AF). At the present time, circumferential PVI (CPVI) using irrigated radiofrequency (RF) is the mostly used ablation technique. However, for CPVI, precise catheter navigation and excellent catheter stability is crucial thereby requiring experienced operators. Robotic navigation systems have been introduced to facilitate catheter navigation and to improve catheter stability, therefore potentially increasing procedural success and making CPVI accessible to less experienced operators. To date, no prospective randomized trial has evaluated the efficacy and safety of CPVI using RNS compared to manually performed ablation.
  
  
  METHODS
  In this prospective international multicenter noninferiority trial, 258 patients with either paroxysmal or short-standing persistent AF will be randomized for comparison of PVI using either manual or robotic ablation. In all patients, CPVI will be performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint of the trial is the absence of AF or atrial tachycardia without antiarrhythmic drug therapy during 12-month follow-up. Secondary endpoints will be evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, as well as the incidence of esophageal injury assessed by endoscopy within 48 hours after the procedure.
  
  
  CONCLUSIONS
  The "Man and Machine Trial" is the first prospective international randomized controlled multicenter noninferiority trial to compare manually performed CPVI with robotically navigated CPVI, evaluating both the safety and efficacy of the 2 techniques during a 12-month follow-up period.
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Rillig
authors.forename: Boris
authors.initials: B
authors.lastname: Schmidt
authors.forename: Daniel
authors.initials: D
authors.lastname: Steven
authors.forename: Udo
authors.initials: U
authors.lastname: Meyerfeldt
authors.forename: Luigi
authors.initials: L
authors.lastname: DI Biase
authors.forename: Erik
authors.initials: E
authors.lastname: Wissner
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Becker
authors.forename: Dierk
authors.initials: D
authors.lastname: Thomas
authors.forename: Peter
authors.initials: P
authors.lastname: Wohlmuth
authors.forename: G Joseph
authors.initials: GJ
authors.lastname: Gallinghouse
authors.forename: Eberhardt
authors.initials: E
authors.lastname: Scholz
authors.forename: Werner
authors.initials: W
authors.lastname: Jung
authors.forename: Stefan
authors.initials: S
authors.lastname: Willems
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Feifan
authors.initials: F
authors.lastname: Ouyang
authors.forename: Karl Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Roland
authors.initials: R
authors.lastname: Tilz
mesh_terms: D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000601:surgery*; D017115:Catheter Ablation / Q000379:methods*; D005260:Female; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D012371:Robotics / Q000379:methods*; D025321:Surgery, Computer-Assisted / Q000379:methods*; D016896:Treatment Outcome