Radiofrequency Ablation (RFA) Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation (MANTRA-PAF)
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ClinicalTrials.gov Identifier: NCT00133211 |
Recruitment Status :
Completed
First Posted : August 23, 2005
Last Update Posted : March 6, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | August 22, 2005 | |||
First Posted Date ICMJE | August 23, 2005 | |||
Last Update Posted Date | March 6, 2015 | |||
Study Start Date ICMJE | September 2005 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Atrial fibrillation burden [ Time Frame: Two years ] | |||
Original Primary Outcome Measures ICMJE |
Atrial fibrillation burden | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Radiofrequency Ablation (RFA) Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation | |||
Official Title ICMJE | Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: A Randomized Prospective Multicentre Study (MANTRA-PAF) | |||
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: The present study is designed to test whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in suppressing long-term relapse of symptomatic and/or asymptomatic atrial fibrillation in patients who are not already in chronic pharmaceutical antiarrhythmic therapy. Secondary end points are: mortality, thromboembolic events, hospitalization due to disturbance in heart rhythm, proarrhythmic events, procedure/treatment related side effects, health economics and quality of life. Comparison will be made after two years follow-up and a register follow-up will take place after additional 3 years (a total of at least five years of follow-up). Consecutive patients fulfilling the inclusion criteria will be informed about the study by a study-responsible electrophysiologist or his/her substitute. After informed consent the patient will be randomized to either antiarrhythmic drug treatment or to catheter ablation. All patients undergo transthoracic echocardiography before randomization. A register of all patients informed about (i.e. fulfilling the inclusion criteria) but for one or more reasons not included in the study will be established. Primary endpoint: Atrial fibrillation burden (see below), symptomatic and asymptomatic combined. Atrial fibrillation burden will be calculated from one-week Holter monitoring at 3, 6, 12, 18 and 24 months, respectively, after treatment (first RF-procedure or AAD-initiation). Secondary endpoints:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Atrial Fibrillation | |||
Intervention ICMJE | Procedure: Radiofrequency ablation
Pulmonary vein isolation
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
294 | |||
Original Enrollment ICMJE |
300 | |||
Actual Study Completion Date ICMJE | September 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 71 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00133211 | |||
Other Study ID Numbers ICMJE | sks2005psh01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jens Cosedis Nielsen, Aarhus University Hospital | |||
Study Sponsor ICMJE | Danish Heart Foundation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Danish Heart Foundation | |||
Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |