Radiofrequency Ablation (RFA) Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation - Full Text View

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 III

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics:

Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: A Randomized Prospective Multicentre Study (MANTRA-PAF)

Further study details as provided by Danish Heart Foundation:

Primary Outcome Measures:

Atrial fibrillation burden [ Time Frame: Two years ]

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Active Comparator Antiarrythmic drug treatment	Procedure: Radiofrequency ablation Pulmonary vein isolation
2: Experimental	Procedure: Radiofrequency ablation Pulmonary vein isolation

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133211

Contacts


Contact: Jens C Nielsen, MD, DMSc	+45 8949 6259	cosedis@dadlnet.dk

Contact: Henriette Holmberg, Secretary	+45 89496259	hhl@sks.aaa.dk

Locations


Denmark
	Department of Cardiology	Recruiting
	Aarhus, Denmark, 8200
	Contact: Jens C Nielsen, MD, DMSc +8949 6259 cosedis@dadlnet.dk
	Principal Investigator: Jens C Nielsen, MD, DMSc

Sponsors and Collaborators

Danish Heart Foundation

Investigators


Principal Investigator:	Jens C Nielsen, MD, DMSc	Aarhus University

More Information

Study ID Numbers:	sks2005psh01, NCT00133211
First Received:	August 22, 2005
Last Updated:	November 6, 2007
ClinicalTrials.gov Identifier:	NCT00133211
Health Authority:	Denmark: National Board of Health

Keywords provided by Danish Heart Foundation:

Paroxysmal atrial fibrillation

Heart arrhythmia

Ablation

Drug treatment

Study placed in the following topic categories:

Heart Diseases

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Danish Heart Foundation
Information provided by:	Danish Heart Foundation
ClinicalTrials.gov Identifier:	NCT00133211