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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Collaborators:
St. Jude Medical
Biosense Webster, Inc.
Information provided by (Responsible Party):
Douglas L. Packer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00911508
First received: May 28, 2009
Last updated: January 20, 2014
Last verified: January 2014

May 28, 2009
January 20, 2014
August 2009
September 2017   (final data collection date for primary outcome measure)
LA catheter ablation is superior to rate or rhythm control drug therapy for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients warranting therapy for AF. [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
Percutaneous left atrial catheter ablation for the purpose of eliminating AF is superior to current state-of-the-art therapy with either rate or rhythm control drugs for reducing total mortality in patients with untreated or under-treated AF. [ Time Frame: 6 month intervals, duration of trial ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00911508 on ClinicalTrials.gov Archive Site
  • LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Total mortality or cardiovascular hospitalization [ Time Frame: From date of enrollment until date of death or CV hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiovascular death [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Cardiovascular death or disabling stroke [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Arrhythmic death or cardiac arrest [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Heart failure death [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Freedom from recurrent AF [ Time Frame: From date of therapy initiation until date of first AF recurrence following a 90 day wait period ] [ Designated as safety issue: No ]
  • Cardiovascular hospitalization [ Time Frame: From date of enrollment until date of hospitalization ] [ Designated as safety issue: Yes ]
  • Medical costs, resource utilization, and cost effectiveness [ Time Frame: From date of enrollment through follow-up (average of 5 years) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: At months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: No ]
  • Composite adverse events [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Left atrial size, morphology and function and its relationship to morbidity and mortality [ Time Frame: Baseline compared with 3-6 months post therapy initiation ] [ Designated as safety issue: No ]
  • Composite endpoints of total mortality, disabling stroke, serious bleeding, and cardiac arrest in patients with untreated or incompletely treated AF warranting therapy. [ Time Frame: 6 month intervals, duation of trial ] [ Designated as safety issue: Yes ]
  • Cardiovascular hospitalization [ Time Frame: 6 month intervals, length of trial ] [ Designated as safety issue: Yes ]
  • Freedom from recurrent AF [ Time Frame: Monitored monthly for trial duration ] [ Designated as safety issue: Yes ]
  • Medical costs, resource utilization, and cost effectiveness [ Time Frame: 6 month intervals, length of trial ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: at months 3,6,12,18,24,30,36 ] [ Designated as safety issue: No ]
  • Composite adverse events [ Time Frame: 6 month intervals, duration of trial ] [ Designated as safety issue: Yes ]
  • LA size, morphology and function [ Time Frame: Baseline and 3 month post therapy initiation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Arrhythmia
  • 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

  • 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

  • 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.
    Intervention: Device: Left atrial 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.
    Intervention: Drug: Rate or Rhythm Control Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2200
March 2018
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Over the preceding 6 months have:

    1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) 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 BP >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, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or 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 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, PCI, or valve or bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy (outflow track)
  • Class IV angina or Class IV CHF (including past or planned heart transplantation)
  • Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, 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.
Both
18 Years to 90 Years
No
Contact: Kristi H. Monahan, RN, BS 507-255-6676 CABANA@mayo.edu
Contact: Mona Branstad 507-538-4358 CABANA@mayo.edu
United States,   Australia,   Canada,   China,   Czech Republic,   Germany,   Italy,   Korea, Republic of,   Russian Federation,   United Kingdom
 
NCT00911508
08-007043 09-004616, U01HL089709
Yes
Douglas L. Packer, Mayo Clinic
Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)
  • St. Jude Medical
  • Biosense Webster, Inc.
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)
Mayo Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP