Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial (CABANA)

This study has been completed.
Sponsor:
Collaborators:
Duke Clinical Research Institute
St. Jude Medical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00578617
First received: December 14, 2007
Last updated: December 3, 2012
Last verified: December 2012

December 14, 2007
December 3, 2012
September 2006
February 2009   (final data collection date for primary outcome measure)
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up [ Time Frame: 12 months after intervention ] [ Designated as safety issue: No ]
Documentation of atrial fibrillation using a cardiac event recorder
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: Trial length ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00578617 on ClinicalTrials.gov Archive Site
Not Provided
  • A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest. [ Time Frame: Trial length ] [ Designated as safety issue: Yes ]
  • Medical costs and resource utilization and cost effectiveness [ Time Frame: Trial length ] [ Designated as safety issue: No ]
  • Composite adverse events [ Time Frame: Trial length ] [ Designated as safety issue: Yes ]
  • Determine the impact of age, AF type, symptom state, and presence of underlying disease on these outcomes and establish the importance of AF elimination in this population of patients. [ Time Frame: Trial length ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 3 months and annual ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Arrhythmia
  • Drug: Rate Control
    Metoprolol 50-100mg
    Other Name: Toprol
  • Device: Ablation Therapy
    Other Name: St. Jude: Livewire
  • Drug: Rate Control
    Atenolol 50-100mg,
    Other Name: Tenormin
  • Drug: Rate control
    Propranolol 40-80mg
    Other Name: Inderal
  • Drug: Rate control
    Acebutolol 200mg
    Other Name: Sectral
  • Drug: Rate control
    Carvedilol 6.25mg
    Other Name: Coreg
  • Drug: Rate Control
    Diltiazem 180-240mg
    Other Name: Cardizem
  • Drug: Rate Control
    Verapamil 180-240mg
    Other Name: Calan
  • Drug: Rate Control
    Digoxin 0.125mg
    Other Name: Lanoxin
  • Drug: Rhythm Control
    Propafenone 450mg
    Other Name: Rhythmol
  • Drug: Rhythm control
    Flecainide 200mg
    Other Name: Tambacor
  • Drug: Rhythm control
    Sotalol 240mg
    Other Name: Betapace
  • Drug: Rhythm control
    Dofetilide 500mcg
    Other Name: Tykosin
  • Drug: Rhythm control
    Amiodarone 200mg
    Other Name: Cordarone
  • Drug: Rhythm control
    Quinidine 600-900mg
    Other Name: Quini-glute/dex
  • Active Comparator: Pharmacologic Therapy
    Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug.
    Interventions:
    • Drug: Rate Control
    • Drug: Rate Control
    • Drug: Rate control
    • Drug: Rate control
    • Drug: Rate control
    • Drug: Rate Control
    • Drug: Rate Control
    • Drug: Rate Control
    • Drug: Rhythm Control
    • Drug: Rhythm control
    • Drug: Rhythm control
    • Drug: Rhythm control
    • Drug: Rhythm control
    • Drug: Rhythm control
  • Active Comparator: Ablation Therapy
    Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
    Intervention: Device: Ablation Therapy
Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have documented AF, which warrants active drug or ablative treatment
  • Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs
  • Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography

Exclusion Criteria:

  • Previously failed 2 or more membrane active anti-arrhythmic drugs
  • Efficacy failure of a full dose Amiodarone trial of >12 weeks duration
  • Any amiodarone therapy in the past three months
  • Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
  • Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age
  • Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy
  • Class IV angina or congestive heart failure
  • Planned heart transplantation
  • Other mandated anti-arrhythmic drug therapy
  • Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs
  • Prior left atrial catheter ablation with the intention to treat AF
  • Patients with other arrhythmias requiring ablative therapy
  • Prior surgical interventions for AF such as the MAZE procedure
  • Prior atrioventricular nodal ablation
  • Medical conditions limiting expected survival to <1 year
  • Contraindication to warfarin anti-coagulation
  • Women of childbearing potential
  • Participation in any other clinical mortality trial
  • Unable to give informed consent
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00578617
06-003867
Yes
Douglas L. Packer, MD, Mayo Clinic
Mayo Clinic
  • Duke Clinical Research Institute
  • St. Jude Medical
Principal Investigator: Douglas L. Packer, M.D. Mayo Clinic
Mayo Clinic
December 2012

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