Please note the ANZCTR will be unattended from Friday 24 December 2021 for the holidays. The Registry will re-open on Monday 17 January 2022. Submissions and updates will not be processed during that time.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Secondary ID [1] 0 0
U01HL089709
Secondary ID [2] 0 0
09-004616
Universal Trial Number (UTN)
Trial acronym
CABANA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. - 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.
Timepoint [1] 0 0
From date of enrollment until time-to-first event over a median follow-up of 48.5 months.
Secondary outcome [1] 0 0
Number of Participants With All-cause Mortality - All deaths were reviewed and adjudicated by the Clinical Events Committee
Timepoint [1] 0 0
From date of enrollment until date of death over a median follow-up of 48.5 months.
Secondary outcome [2] 0 0
Number of Participants With Mortality or Cardiovascular (CV) Hospitalization - Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.
Timepoint [2] 0 0
From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.
Secondary outcome [3] 0 0
Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) - 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.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Number of Participants With Cardiovascular Death - Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator
Timepoint [4] 0 0
From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.
Secondary outcome [5] 0 0
Number of Participants With Cardiovascular Death or Disabling Stroke - Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale =2.
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Number of Participants With an Arrhythmic Death or Cardiac Arrest - All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Number of Participants With Heart Failure Death - All deaths were categorized and adjudicated by the Clinical Events Committee
Timepoint [7] 0 0
From date of enrollment until date of heart failure death over a median follow-up of 48.5 months.
Secondary outcome [8] 0 0
Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period - 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.
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Number of Participants With Cardiovascular Hospitalization - The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.
Timepoint [9] 0 0
From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.
Secondary outcome [10] 0 0
Changes in Quality of Life Measures - AFEQT - 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).
Timepoint [10] 0 0
Baseline ,12 month, 5 years
Secondary outcome [11] 0 0
Changes in Quality of Life Measures - MAFSI Frequency Score - 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).
Timepoint [11] 0 0
Baseline, 12 Month, 5 Year
Secondary outcome [12] 0 0
Changes in Quality of Life Measures - MAFSI Severity Score - 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).
Timepoint [12] 0 0
Baseline, 12 Month, 5 Year
Secondary outcome [13] 0 0
Number of Participants With Adverse Events/Complications - 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.
Timepoint [13] 0 0
From treatment start date to date of event over a median follow-up of 48.5 months.

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.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
China
State/province [32] 0 0
Guangdong
Country [33] 0 0
China
State/province [33] 0 0
Jiangsu
Country [34] 0 0
China
State/province [34] 0 0
Liaoning
Country [35] 0 0
China
State/province [35] 0 0
Beijing
Country [36] 0 0
Czechia
State/province [36] 0 0
Hlavni Mesto Praha
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Prague 2
Country [39] 0 0
Czechia
State/province [39] 0 0
Prague 4
Country [40] 0 0
Germany
State/province [40] 0 0
Baden-Wurttemberg
Country [41] 0 0
Germany
State/province [41] 0 0
Bayern
Country [42] 0 0
Germany
State/province [42] 0 0
Freie-Hansestadt Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Nordrhein-Westfalen
Country [44] 0 0
Germany
State/province [44] 0 0
Saxony
Country [45] 0 0
Germany
State/province [45] 0 0
Bad Nauheim
Country [46] 0 0
Germany
State/province [46] 0 0
Dresden
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt
Country [48] 0 0
Germany
State/province [48] 0 0
Gottingen
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Karlsruhe
Country [51] 0 0
Germany
State/province [51] 0 0
Leipzig
Country [52] 0 0
Germany
State/province [52] 0 0
Rostock
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Milan
Country [55] 0 0
Italy
State/province [55] 0 0
Varese
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Novosibirskaya Oblast
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Moscow
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Tomsk
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Glasgow
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Mayo Clinic
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Abbott Medical Devices
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Biosense Webster, Inc.
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00911508
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas L. Packer, M.D.
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications