Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: A Randomized Prospective Multicentre Study (MANTRA-PAF)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 294
- Locations
- 1
- Primary Endpoint
- Atrial fibrillation burden
Study Overview
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.
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 atrial fibrillation. Several studies have shown older patients with paroxysmal or persistent atrial fibrillation and with minor symptoms related to the arrhythmia do equally well on a frequency control as compared to a rhythm control strategy. However, some of this lack of difference in outcome may be because the benefits by achieving sinus rhythm are outbalanced by the risk of medication with presently known antiarrhythmic drugs together with the only modest efficacy of these drugs. Non-pharmacological treatment of atrial fibrillation has drawn increasing interest over the last decade, and especially percutaneous catheter based ablation strategies have been in focus with promising results on the symptomatic level in several series of patients. Different technologies have been in use with very few comparative studies. Most important, no study has been published so far on a consecutive series of patients with atrial fibrillation randomized to either a pharmacological or an ablative strategy. Also important is that the majority of studies have been single-centre based prone to a multitude of potential selection biases.
Hypothesis:
Pulmonary vein isolation by transvenous radiofrequency ablation is superior to present time antiarrhythmic drug therapy with regard to long-term suppression of atrial fibrillation (symptomatic and asymptomatic) as well as to procedure/treatment related side effects.
Purpose:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 71 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
1
Antiarrythmic drug treatment
Intervention: Radiofrequency ablation (Procedure)
2
Intervention: Radiofrequency ablation (Procedure)
Outcomes
Primary Outcomes
Atrial fibrillation burden
Time Frame: Two years
Secondary Outcomes
- Health economics(2 years)
- mortality(2 years)
- complications to treatment(2 years)
- Quality of life(2 years)
Investigators
Jens Cosedis Nielsen
MD, DMSc, associate professor
Aarhus University Hospital