title: The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation.
abstract: OBJECTIVE
  No large randomized multicentre trial has evaluated the efficacy of radiofrequency ablation (RFA) vs. anti-arrhythmic drug (AAD) therapy as a first-line treatment of paroxysmal atrial fibrillation (AF).
  
  
  RESULTS
  The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation (MANTRA-PAF) trial is a randomized, controlled, parallel group, multicentre study designed to test whether catheter-based RFA is superior to optimized AAD therapy in suppressing relapse within 24 months of symptomatic and/or asymptomatic AF in patients with paroxysmal AF without prior AAD therapy. The primary endpoint is cumulative AF burden on repeated 7 days Holter monitoring. Secondary endpoints are: thromboembolic events, hospitalization due to arrhythmia, pro-arrhythmic events, procedure/treatment-related side effects, health economics, quality of life, and change in left ventricular function. Ten centres in Scandinavia and Germany are participating in the study. Enrolment was started in 2005 and as of November 2008, 260 patients have been enrolled into the study. It is expected that enrolment will end by March 2009, when 300 patients have been included.
  
  
  CONCLUSIONS
  The MANTRA-PAF trial will determine whether catheter-based RFA is superior to optimized AAD therapy as a first-line treatment in suppressing long-term relapse of symptomatic and/or asymptomatic AF.
authors.affiliation: Gentofte University Hospital, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Jons
authors.forename: Peter Steen
authors.initials: PS
authors.lastname: Hansen
authors.forename: Arne
authors.initials: A
authors.lastname: Johannessen
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hindricks
authors.forename: Pekka
authors.initials: P
authors.lastname: Raatikainen
authors.forename: Ole
authors.initials: O
authors.lastname: Kongstad
authors.forename: Håkan
authors.initials: H
authors.lastname: Walfridsson
authors.forename: Steen
authors.initials: S
authors.lastname: Pehrson
authors.forename: Henrik
authors.initials: H
authors.lastname: Almroth
authors.forename: Juha
authors.initials: J
authors.lastname: Hartikainen
authors.forename: Anders Kirstein
authors.initials: AK
authors.lastname: Petersen
authors.forename: Leif Spange
authors.initials: LS
authors.lastname: Mortensen
authors.forename: Jens Cosedis
authors.initials: JC
authors.lastname: Nielsen
mesh_terms: D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects* / Q000379:methods*; D005858:Germany; D006801:Humans; D011183:Postoperative Complications / Q000175:diagnosis* / Q000209:etiology*; D012107:Research Design; D013548:Sweden; D016896:Treatment Outcome