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The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) Trial: clinical rationale, study design, and implementation

Jons, Christian; Hansen, Peter Steen; Johannessen, Arne; Hindricks, Gerhard; Raatikainen, Pekka; Kongstad Rasmussen, Ole LU ; Walfridsson, Hakan; Pehrson, Steen; Almroth, Henrik and Hartikainen, Juha, et al. (2009) In Europace 11(7). p.917-923
Abstract
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). 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... (More)
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). 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. 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. (Less)
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Contribution to journal
publication status
published
subject
keywords
Anti-arrhythmic drugs, Atrial fibrillation, Radiofrequency ablation, Randomized trial
in
Europace
volume
11
issue
7
pages
917 - 923
publisher
Oxford University Press
external identifiers
  • wos:000267441000016
  • scopus:67650866688
ISSN
1532-2092
DOI
10.1093/europace/eup122
language
English
LU publication?
yes
id
ac9bae15-ffa6-4a62-a79d-b1635fc00c88 (old id 1463262)
date added to LUP
2009-08-31 10:57:13
date last changed
2017-08-13 03:46:52
@article{ac9bae15-ffa6-4a62-a79d-b1635fc00c88,
  abstract     = {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). 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. 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.},
  author       = {Jons, Christian and Hansen, Peter Steen and Johannessen, Arne and Hindricks, Gerhard and Raatikainen, Pekka and Kongstad Rasmussen, Ole and Walfridsson, Hakan and Pehrson, Steen and Almroth, Henrik and Hartikainen, Juha and Petersen, Anders Kirstein and Mortensen, Leif Spange and Nielsen, Jens Cosedis},
  issn         = {1532-2092},
  keyword      = {Anti-arrhythmic drugs,Atrial fibrillation,Radiofrequency ablation,Randomized trial},
  language     = {eng},
  number       = {7},
  pages        = {917--923},
  publisher    = {Oxford University Press},
  series       = {Europace},
  title        = {The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) Trial: clinical rationale, study design, and implementation},
  url          = {http://dx.doi.org/10.1093/europace/eup122},
  volume       = {11},
  year         = {2009},
}