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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133211
First Posted: August 23, 2005
Last Update Posted: March 6, 2015
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.
Information provided by (Responsible Party):
Jens Cosedis Nielsen, Aarhus University Hospital
  Purpose
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 Intervention Phase
Atrial Fibrillation Procedure: Radiofrequency ablation Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Jens Cosedis Nielsen, Aarhus University Hospital:

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

Secondary Outcome Measures:
  • mortality [ Time Frame: 2 years ]
  • complications to treatment [ Time Frame: 2 years ]
  • Quality of life [ Time Frame: 2 years ]
  • Health economics [ Time Frame: 2 years ]

Enrollment: 294
Study Start Date: September 2005
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Antiarrythmic drug treatment
Procedure: Radiofrequency ablation
Pulmonary vein isolation
Experimental: 2 Procedure: Radiofrequency ablation
Pulmonary vein isolation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00133211


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Nielsen JC, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Pehrson SM, Englund A, Hartikainen J, Mortensen LS, Hansen PS; MANTRA-PAF Investigators. Long-term efficacy of catheter ablation as first-line therapy for paroxysmal atrial fibrillation: 5-year outcome in a randomised clinical trial. Heart. 2017 Mar;103(5):368-376. doi: 10.1136/heartjnl-2016-309781. Epub 2016 Aug 26.
Walfridsson H, Walfridsson U, Nielsen JC, Johannessen A, Raatikainen P, Janzon M, Levin LA, Aronsson M, Hindricks G, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial. Europace. 2015 Feb;17(2):215-21. doi: 10.1093/europace/euu342. Epub 2015 Jan 6.
Aronsson M, Walfridsson H, Janzon M, Walfridsson U, Nielsen JC, Hansen PS, Johannessen A, Raatikainen P, Hindricks G, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Levin LÅ. The cost-effectiveness of radiofrequency catheter ablation as first-line treatment for paroxysmal atrial fibrillation: results from a MANTRA-PAF substudy. Europace. 2015 Jan;17(1):48-55. doi: 10.1093/europace/euu188. Epub 2014 Oct 23.
Cosedis Nielsen J, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012 Oct 25;367(17):1587-95. doi: 10.1056/NEJMoa1113566.

Responsible Party: Jens Cosedis Nielsen, MD, DMSc, associate professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00133211     History of Changes
Other Study ID Numbers: sks2005psh01
First Submitted: August 22, 2005
First Posted: August 23, 2005
Last Update Posted: March 6, 2015
Last Verified: March 2015

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

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


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