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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Danish Heart Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jens Cosedis Nielsen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00133211
First received: August 22, 2005
Last updated: October 4, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Danish Heart Foundation:

Primary Outcome Measures:
  • Atrial fibrillation burden [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • complications to treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Health economics [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2005
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Danish Heart Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jens Cosedis Nielsen, MD, DMSc, associate professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00133211     History of Changes
Other Study ID Numbers: sks2005psh01
Study First Received: August 22, 2005
Last Updated: October 4, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by Danish Heart Foundation:
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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014