Status:
COMPLETED
Radiofrequency Ablation (RFA) Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation
Lead Sponsor:
Danish Heart Foundation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-71 years
Phase:
PHASE3
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 s...
Detailed Description
Introduction: Atrial fibrillation is by far the most common heart arrhythmia and is even increasing in prevalence and incidence. Approximately 10% of all cardiologic hospitalizations are due to atria...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT00133211
Start Date
September 1 2005
End Date
September 1 2014
Last Update
March 6 2015
Active Locations (1)
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1
Department of Cardiology
Aarhus, Denmark, 8200