A randomised clinical trial investigating the effect of catheter ablation versus control in patients with untreated or incompletely treated AF
| Studied treatment |
left atrial catheter ablation Pulmonary vein isolation using a circumferential ablative approach in the left atrium. Ablation may be performed using circular mapping catheter-guided ablation, antral isolation using a circular guided approach, or wide area circumferential ablation. |
| Control treatment |
current state-of-the-art therapy with either rate control or rhythm control drugs Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg |
| Patients | patients with untreated or incompletely treated AF |
| Size | 3000 |
| Inclusion criteria | documented AF episodes =1 hour in duration; with =2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week; warrant active therapy beyond simple ongoing observation; eligible for both catheter ablation and >=2 sequential rhythm control and/or >=3 rate control drugs; >=65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure, Prior stroke or TIA, LA size >=5.0 cm (or volume index >=40 cc/m2), or EF >=35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify. |
| Exclusion criteria | lone AF in the absence of risk factors for stroke in patients <65 years of age; patients who in the opinion of the managing clinician should not yet receive any therapy for AF; patients who have failed =2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy; more than one week of amiodarone treatment in the past 3 months; an efficacy failure of full dose amiodarone treatment =12 weeks duration at any time; reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma; recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months; hypertrophic obstructive cardiomyopathy; class IV angina or Class IV CHF (including past or planned heart transplantation); other mandated anti-arrhythmic drug therapy; heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs; prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE procedure; prior AV nodal ablation; patients with other arrhythmias requiring ablative therapy; contraindication to warfarin anti-coagulation; renal failure requiring dialysis; medical conditions limiting expected survival to <1 year; women of childbearing potential (unless post-menopausal or surgically sterile) |
| LVEF |
| Blindness | open | Inclusion period | Aug 2009 - |
| Follow-up duration | Centers | ||
| Lost to FU | geographical localisation | ||
| Primary endpoint | total mortality | Design | Parallel groups |
| PeriodeInclusion | Aug 2009 - | ||
| duration of symptoms | |||
| previous antiarhythmic drugs | |||
| paroxysmal AF | |||
| chronic AF | |||
| Type of atrial fibrillation |
ClinicalTrial.gov record NCT00911508).
All trials of catheter ablation
Appears in following systematic reviews:
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