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Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00911508
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott Medical Devices
Biosense Webster, Inc.
Information provided by (Responsible Party):
Douglas L. Packer, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Arrhythmia Device: Left atrial ablation Drug: Rate or Rhythm Control Therapy Not Applicable

Detailed Description:

The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment.

The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Actual Study Start Date : November 13, 2009
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: 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


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.
Drug: 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





Primary Outcome Measures :
  1. Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. [ Time Frame: From date of enrollment until time-to-first event over a median follow-up of 48.5 months. ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With All-cause Mortality [ Time Frame: From date of enrollment until date of death over a median follow-up of 48.5 months. ]
    All deaths were reviewed and adjudicated by the Clinical Events Committee

  2. Number of Participants With Mortality or Cardiovascular (CV) Hospitalization [ Time Frame: From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months. ]
    Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.

  3. Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) [ Time Frame: 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. ]
    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.

  4. Number of Participants With Cardiovascular Death [ Time Frame: From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months. ]
    Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator

  5. Number of Participants With Cardiovascular Death or Disabling Stroke [ Time Frame: 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. ]
    Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2.

  6. Number of Participants With an Arrhythmic Death or Cardiac Arrest [ Time Frame: 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. ]
    All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee

  7. Number of Participants With Heart Failure Death [ Time Frame: From date of enrollment until date of heart failure death over a median follow-up of 48.5 months. ]
    All deaths were categorized and adjudicated by the Clinical Events Committee

  8. Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period [ Time Frame: 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. ]
    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.

  9. Number of Participants With Cardiovascular Hospitalization [ Time Frame: From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months. ]
    The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.

  10. Changes in Quality of Life Measures - AFEQT [ Time Frame: Baseline ,12 month, 5 years ]
    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).

  11. Changes in Quality of Life Measures - MAFSI Frequency Score [ Time Frame: Baseline, 12 Month, 5 Year ]
    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).

  12. Changes in Quality of Life Measures - MAFSI Severity Score [ Time Frame: Baseline, 12 Month, 5 Year ]
    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).

  13. Number of Participants With Adverse Events/Complications [ Time Frame: From treatment start date to date of event over a median follow-up of 48.5 months. ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911508


Locations
Show Show 118 study locations
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Abbott Medical Devices
Biosense Webster, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Douglas L. Packer, M.D. Mayo Clinic
Principal Investigator: Kerry L. Lee, Ph.D. Duke Clinical Research Institute
Principal Investigator: Daniel B. Mark, M.D., MPH Duke Clinical Research Institute
Principal Investigator: Rich A. Robb, Ph.D. Phy Mayo Clinic
Study Chair: Yves D. Rosenberg, M.D., MPH National Heart, Lung, and Blood Institute (NHLBI)
  Study Documents (Full-Text)

Documents provided by Douglas L. Packer, Mayo Clinic:
Study Protocol  [PDF] November 22, 2013
Statistical Analysis Plan  [PDF] February 26, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00911508    
Other Study ID Numbers: 09-004616
U01HL089709 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2009    Key Record Dates
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by Douglas L. Packer, Mayo Clinic:
Atrial Fibrillation
Left Atrial Ablation
Pulmonary Vein Isolation
Catheter Ablation
Antiarrhythmic Drug Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes