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

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Left atrial ablation Device
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Ablation
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Left Atrial Ablation
    Description: 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.
  • Rate or Rhythm Control Therapy Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Rate or Rhythm Control Therapy
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 incompletely treated AF. 6 month intervals, duration of trial Yes
Secondary Decrease the composite endpoint of total mortality, disabling stroke, serious bleeding, and cardiac arrest in patients with untreated or incompletely treated AF warranting therapy. 6 month intervals, duration of trial Yes
Secondary Total mortality, disabling stroke, serious bleeding, or cardiac arrest 6 month intervals, length of trial Yes
Secondary Total mortality or cardiovascular hospitalization 6 month intervals, duration of trial Yes
Secondary Cardiovascular death 6 month intervals, length of trial Yes
Secondary Cardiovascular death or disabling stroke 6 month intervals, duration of trial Yes
Secondary Arrhythmic death or cardiac arrest 6 month intervals, duration of trial Yes
Secondary Heart failure death LA size, morphology and function 6 month intervals, duration of trial Yes
Secondary Freedom from recurrent AF Monitored monthly for trial duration No
Secondary Cardiovascular hospitalization 6 month intervals, duration of trial Yes
Secondary Medical costs, resource utilization, and cost effectiveness 6 month intervals, duration of trial No
Secondary Quality of Life At months 3, 6, 12, 18, 24, 30, 36 No
Secondary Composite adverse events 6 month intervals, duration of trial Yes
Secondary Left atrial size, morphology and function Baseline and 3 months post therapy initiation No
Primary Left atrial catheter ablation is superior to drug therapy with either rate or rhythm control drugs for reducing total mortality From date of enrollment until date of death Yes
Secondary Decrease the composite endpoint of total mortality, disabling stroke, serious bleeding, and cardiac arrest. From date of enrollment until date of event Yes
Secondary Heart failure death From date of enrollment until date of event Yes
Primary 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. From date of enrollment until date of event Yes
Secondary LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality From date of enrollment until date of death Yes
Secondary Left atrial size, morphology and function and its relationship to morbidity and mortality Baseline compared with 3-6 months post therapy initiation No

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