Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Condition: Atrial Fibrillation; Arrhythmia
MeSH terms: Atrial Fibrillation
Study type: Interventional

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.
    

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.
    

Intervention name(s): Left atrial ablation; Rate or Rhythm Control Therapy
Intervention type(s): Device; Drug
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Left Atrial Ablation; Pulmonary Vein Isolation; Catheter Ablation; Antiarrhythmic Drug Therapy