CABANA, trial summary

Ongoing trial

PDF trial summary

A randomised clinical trial investigating the effect of catheter ablation versus control in patients with untreated or incompletely treated AF

NCT00911508).

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).

Registering number	NCT00911508). (see trial on clinicaltrials.gov)
Code Name

All trials of catheter ablation

Appears in following systematic reviews:

atrial fibrillation > catheter ablation