Radiofrequency Ablation (RFA) Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation (MANTRA-PAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133211
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):
Jens Cosedis Nielsen, Aarhus University Hospital

Brief Summary:
Atrial fibrillation is the most common heart arrhythmia afflicting approximately 1% of the Danish population. Medical antiarrhythmic treatment is only moderately effective and has the risk of severe side effects. The present study is a prospective, randomized, multicentre study comparing medical antiarrhythmic drug strategy with catheter based radiofrequency strategy in patients with paroxysmal atrial fibrillation. The primary end point is atrial fibrillation burden (symptomatic and asymptomatic) judged by multiple 7-day Holter monitorings during 2 years follow-up. Three hundred patients considered candidates for antiarrhythmic drug treatment will be randomized. The study will be performed as a Scandinavian/German multicentre study.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Radiofrequency ablation Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: A Randomized Prospective Multicentre Study (MANTRA-PAF)
Study Start Date : September 2005
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Antiarrythmic drug treatment
Procedure: Radiofrequency ablation
Pulmonary vein isolation

Experimental: 2 Procedure: Radiofrequency ablation
Pulmonary vein isolation

Primary Outcome Measures :
  1. Atrial fibrillation burden [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 2 years ]
  2. complications to treatment [ Time Frame: 2 years ]
  3. Quality of life [ Time Frame: 2 years ]
  4. Health economics [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≤ 70 years of age
  • Paroxysmal atrial fibrillation patients who are considered as being candidates for antiarrhythmic drug therapy initiation
  • Patients who have had at least two episodes of symptomatic paroxysmal atrial fibrillation in the foregoing 6 months can be included. The atrial fibrillation episodes may be persistent (need DC- or AAD-conversion) with a duration of less than 7 days.

Exclusion Criteria:

  • Previous or ongoing chronic treatment with class IC or class III antiarrhythmic drugs
  • Intolerance/contraindication to class IC and class III antiarrhythmic drugs (i.e. intolerance/contraindication to only one of the two groups is not excluding the patient)
  • Previous atrial fibrillation ablation
  • Severely increased left atrial size
  • Left ventricular ejection fraction below 0.40 (during sinus rhythm or atrial fibrillation with RR-intervals above 600 ms) or "eye-balled" reduction of systolic function to less than "moderately decreased".
  • Contraindication to anticoagulation treatment with vitamin K antagonists
  • Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease
  • New York Heart Association (NYHA) III-IV
  • Planned pregnancy within the follow-up period
  • Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism)
  • Age < 18 years
  • Patient does not want to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133211

Department of Cardiology
Aarhus, Denmark, 8200
Sponsors and Collaborators
Danish Heart Foundation
Principal Investigator: Jens Cosedis Nielsen, MD, DMSc Aarhus University Hospital Skejby

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Jens Cosedis Nielsen, MD, DMSc, associate professor, Aarhus University Hospital Identifier: NCT00133211     History of Changes
Other Study ID Numbers: sks2005psh01
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Jens Cosedis Nielsen, Aarhus University Hospital:
Paroxysmal atrial fibrillation
Heart arrhythmia
Drug treatment

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents