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Europace Advance Access originally published online on May 15, 2009
Europace 2009 11(7):917-923; doi:10.1093/europace/eup122
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

Study Design

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

Christian Jons1, Peter Steen Hansen2, Arne Johannessen1, Gerhard Hindricks3, Pekka Raatikainen4, Ole Kongstad5, Håkan Walfridsson6, Steen Pehrson7, Henrik Almroth8, Juha Hartikainen9, Anders Kirstein Petersen2, Leif Spange Mortensen10, Jens Cosedis Nielsen2,* on behalf of the MANTRA-PAF Investigators

1 Gentofte University Hospital, Copenhagen, Denmark; 2 Skejby University Hospital, Aarhus, Denmark; 3 Leipzig University Hospital, Leipzig, Germany; 4 Oulo University Hospital, Finland; 5 Lund University Hospital, Sverige, Sweden; 6 Department of Cardiology, Heartcenter, University Hospital Linköping, Linköping, Sweden; 7 Rigshospitalet, Copenhagen, Denmark; 8 University Hospital, Örebro, Sweden; 9 Kuopio University Hospital, Kuopio, Finland; 10 Uni-C, Aarhus, Denmark

Aims: 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).

Methods and 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.

Conclusion: 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.

Key Words: Atrial fibrillation, Radiofrequency ablation, Anti-arrhythmic drugs, Randomized trial

* Corresponding author: Department of Cardiology B, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark. Tel: +45 89 49 55 66, Fax: +45 89 49 60 02, Email: cosedis{at}dadlnet.dk

Manuscript submitted 8 February 2009. Accepted after revision 22 April 2009.


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