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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00911508
Registration number
NCT00911508
Ethics application status
Date submitted
28/05/2009
Date registered
2/06/2009
Date last updated
21/04/2021
Titles & IDs
Public title
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
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Scientific title
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
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Secondary ID [1]
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U01HL089709
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Secondary ID [2]
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09-004616
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Universal Trial Number (UTN)
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Trial acronym
CABANA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Arrhythmia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Left atrial ablation
Treatment: Drugs - Rate or Rhythm Control Therapy
Active Comparator: Left Atrial 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.
Active Comparator: Rate or Rhythm Control Therapy - Current state-of-the-art drug therapy for atrial fibrillation (rate control or rhythm control). Treating physicians will be encouraged to follow the American College of Cardiology / American Heart Association / European Society of Cardiology Atrial Fibrillation Guidelines with regard to drug therapy for atrial fibrillation. The specific choice of rate control versus rhythm control drug therapy and the specific drugs to be used will ultimately be left to the discretion of the treating physician.
Treatment: Devices: Left atrial ablation
St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path
Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF
Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System
Bard: Stinger
Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath
Treatment: Drugs: Rate or Rhythm Control Therapy
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, Dronedarone 800mg
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.
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Assessment method [1]
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All events for each component of the primary endpoint were reviewed and adjudicated in a blinded fashion by an independent clinical events committee using prospectively determined event definitions. Death was defined as all-cause mortality, disabling stroke (including intracranial bleeding) as an irreversible physical limitation defined by a Rankin Stroke Scale =2, and serious bleeding as bleeding accompanied by hemodynamic compromise that required surgical intervention or a transfusion of =3 units of blood.
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Timepoint [1]
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From date of enrollment until time-to-first event over a median follow-up of 48.5 months.
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Secondary outcome [1]
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Number of Participants With All-cause Mortality
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Assessment method [1]
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All deaths were reviewed and adjudicated by the Clinical Events Committee
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Timepoint [1]
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From date of enrollment until date of death over a median follow-up of 48.5 months.
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Secondary outcome [2]
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Number of Participants With Mortality or Cardiovascular (CV) Hospitalization
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Assessment method [2]
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Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.
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Timepoint [2]
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From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.
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Secondary outcome [3]
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Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events)
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Assessment method [3]
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Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale =2 and the reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.
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Timepoint [3]
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From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months.
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Secondary outcome [4]
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Number of Participants With Cardiovascular Death
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Assessment method [4]
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Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator
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Timepoint [4]
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From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.
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Secondary outcome [5]
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Number of Participants With Cardiovascular Death or Disabling Stroke
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Assessment method [5]
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Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale =2.
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Timepoint [5]
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From date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months.
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Secondary outcome [6]
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Number of Participants With an Arrhythmic Death or Cardiac Arrest
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Assessment method [6]
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All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee
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Timepoint [6]
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From date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months.
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Secondary outcome [7]
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Number of Participants With Heart Failure Death
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Assessment method [7]
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All deaths were categorized and adjudicated by the Clinical Events Committee
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Timepoint [7]
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From date of enrollment until date of heart failure death over a median follow-up of 48.5 months.
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Secondary outcome [8]
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Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period
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Assessment method [8]
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Data from patients using the study provided ECG event recording system were analyzed. A 30-second episode of AF in either group, confirmed through blinded review by an ECG Core Lab Committee was used for defining the endpoint of recurrent AF.
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Timepoint [8]
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From date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months.
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Secondary outcome [9]
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Number of Participants With Cardiovascular Hospitalization
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Assessment method [9]
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The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.
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Timepoint [9]
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From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.
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Secondary outcome [10]
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Changes in Quality of Life Measures - AFEQT
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Assessment method [10]
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Atrial Fibrillation Effect on Quality of Life (AFEQT) Overall Score (Scale: 0 = complete disability, 100 = no disability). The AFEQT is a 21-item AF-specific, health-related QOL questionnaire designed to assess the effect of atrial fibrillation on patient quality of life. The AFEQT has an Overall Score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. Overall and subscale scores range from 0 (corresponds to complete disability) to 100 (no AF-related disability).
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Timepoint [10]
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Baseline ,12 month, 5 years
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Secondary outcome [11]
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Changes in Quality of Life Measures - MAFSI Frequency Score
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Assessment method [11]
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The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI frequency of symptoms over the past month was recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), and 4 (always) for each of the 10 items listed in the questionnaire. The 10 item responses were summed for a total Frequency Score that ranged from 0 (no AF symptoms) to 40 (worst score).
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Timepoint [11]
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Baseline, 12 Month, 5 Year
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Secondary outcome [12]
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Changes in Quality of Life Measures - MAFSI Severity Score
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Assessment method [12]
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The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI severity scores over the past month were recorded as 1 (mild), 2 (moderate), and 3 (extreme) for each of the 10 items listed in the questionnaire. The 10 items items were then summed for the total Severity Score that ranged from 0 (no AF symptoms) to 30 (most severe AF symptoms).
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Timepoint [12]
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Baseline, 12 Month, 5 Year
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Secondary outcome [13]
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Number of Participants With Adverse Events/Complications
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Assessment method [13]
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Comparing individual non-endpoint adverse events between ablative and drug therapy is difficult due to the substantial difference in the types of adverse events expected.
Ablation-related events were counted among all patients that were randomized to and received an ablation.
Drug-related events were counted among all patients that were randomized to and received drug therapy.
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Timepoint [13]
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From treatment start date to date of event over a median follow-up of 48.5 months.
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Eligibility
Key inclusion criteria
- Over the preceding 6 months have:
1. =2 paroxysmal (electrocardiographic documentation of at least 1) atrial
fibrillation (AF) episodes lasting =1 hour in duration: (that terminate
spontaneously within 7 days or cardioversion is performed within 48h of AF
onset): or
2. electrocardiographic documentation of 1 persistent AF episode: (sustained for =7
days or cardioversion is performed more than 48h after AF onset): or
3. electrocardiographic documentation of 1 longstanding persistent AF episode:
(continuous AF of duration >1 year).
- Warrant active therapy (within the past 3 months) beyond simple ongoing observation
- Be eligible for catheter ablation and =2 sequential rhythm control and/or =2 rate
control drugs.
- Be =65 yrs of age, or <65 yrs with one or more of the following risk factors for
stroke: Hypertension (treated and/or defined as a blood pressure >140/90 mmHg) [90],
Diabetes (treated and/or defined as a fasting glucose =126 mg/dl) [91], Congestive
heart failure (including systolic or diastolic heart failure), Prior stroke, transient
ischemic attack or systemic emboli, Atherosclerotic vascular disease (previous
myocardial infarction (MI), peripheral arterial disease or aortic plaque), left atrial
(LA) size >5.0 cm (or volume index =40 cc/m2), or ejection fraction (EF) =35.
- Have the capacity to understand and sign an informed consent form.
- Be =18 years of age.
- NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a
second risk factor or left ventricular (LV) hypertrophy to qualify.Patients
receiving new drug therapy initiated within the previous 3 months may continue
that therapy if randomized to the drug therapy arm. Patients may have documented
atrial flutter in addition to atrial fibrillation and remain eligible for
enrollment.
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Minimum age
18
Years
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Maximum age
90
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 or side effects (Table 5.2.2)
- An efficacy failure of full dose amiodarone treatment >8 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, percutaneous intervention (PCI), or valve or
bypass surgery in the preceding 3 months
- Hypertrophic obstructive cardiomyopathy (outflow track)
- Class IV angina or Class IV congestive heart failure (CHF) (including past or planned
heart transplantation)
- Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. ventricular tachycardia
(VT), ventricular fibrillation (VF))
- 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 appropriate anti-coagulation therapy
- Renal failure requiring dialysis
- Medical conditions limiting expected survival to <1 year
- Women of childbearing potential (unless post-menopausal or surgically sterile)
- Participation in any other clinical mortality trial (Participation in other
non-mortality trials should be reviewed with the clinical trial management center)
- Unable to give informed consent
- NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if
the patient develops subsequent recurrent AF. Planned atrial flutter ablation in
combination with the left atrial ablation is not an exclusion.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2017
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Sample size
Target
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Accrual to date
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Final
2204
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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Brno
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Russian Federation
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Novosibirskaya Oblast
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Tomsk
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Glasgow
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Funding & Sponsors
Primary sponsor type
Other
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Name
Mayo Clinic
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Address
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Name [1]
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National Heart, Lung, and Blood Institute (NHLBI)
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Commercial sector/Industry
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Abbott Medical Devices
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Biosense Webster, Inc.
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Ethics approval
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Summary
Brief summary
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial)
CABANA Trial has the overall goal of establishing the appropriate roles for medical and
ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the
hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of
eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy
with either rate control or rhythm control drugs for decreasing the incidence of the
composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest
in patients with untreated or incompletely treated AF.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00911508
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Douglas L. Packer, M.D.
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Address
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Mayo Clinic
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00911508
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