The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation.
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.
Jons
Christian
C
Gentofte University Hospital, Copenhagen, Denmark.
Hansen
Peter Steen
PS
Johannessen
Arne
A
Hindricks
Gerhard
G
Raatikainen
Pekka
P
Kongstad
Ole
O
Walfridsson
Håkan
H
Pehrson
Steen
S
Almroth
Henrik
H
Hartikainen
Juha
J
Petersen
Anders Kirstein
AK
Mortensen
Leif Spange
LS
Nielsen
Jens Cosedis
JC
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