Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133211
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2005-08-22
Brief Title:
Radiofrequency Ablation RFA Versus Antiarrhythmic Drug Treatment in Paroxysmal Atrial Fibrillation
Sponsor:
Danish Heart Foundation
Organization:
Danish Heart Foundation
Study Overview
Official Title:
Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation A Randomized Prospective Multicentre Study MANTRA-PAF
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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 ScandinavianGerman 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 proceduretreatment 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 andor 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 proceduretreatment 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 hisher 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 ie 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
Mortality
Complications including thromboembolic events major bleeding episodes pro-arrhythmic events and treatment related side effects
QOL
Health economics including number of DC-conversions cardiovascular hospitalizations type length and number of antiarrhythmic drugs
Chronic atrial fibrillation constant atrial fibrillation during one-week Holter monitoring at 24 months follow-up together with atrial fibrillation during the immediately foregoing 8 weeks
Time to first recurrence after 3 months blanking period
Left ventricular systolic function transthoracic echo
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 proceduretreatment 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 andor 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 proceduretreatment 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 hisher 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 ie 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
Mortality
Complications including thromboembolic events major bleeding episodes pro-arrhythmic events and treatment related side effects
QOL
Health economics including number of DC-conversions cardiovascular hospitalizations type length and number of antiarrhythmic drugs
Chronic atrial fibrillation constant atrial fibrillation during one-week Holter monitoring at 24 months follow-up together with atrial fibrillation during the immediately foregoing 8 weeks
Time to first recurrence after 3 months blanking period
Left ventricular systolic function transthoracic echo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCT00133211 | None | None | None |