Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial "CABANA"

Completed

Phase N/A Results

Trial Description

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.

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.

Conditions

Interventions

  • Pharmacologic Therapy Rate and/or Rhythm Control Drug
    Intervention Desc: Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200mg, Carvedilol 6.25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125mg. Rhythm control: Propafenone 450mg, Flecainide 200mg, Sotalol 240mg, Dofetilide 500mcg, Amiodarone 200mg, Quinidine 600-900mg
    ARM 1: Kind: Experimental
    Label: 1
    Description: Pharmacologic Therapy Rate and/or Rhythm Control
  • NAVI-STAR Thermo-cool (Left Atrial Catheter Ablation) Device
    Intervention Desc: St. Jude: Livewire, Therapy Dual / Thermocouple. Biosense Webster: NAVI-STAR/ NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-cool. CryoCath Technologies: Freezor/Freezor Max. Bard: Stinger. Boston Scientific: Blazer II RF/RPM/SteeroCath/XP, Chilli Cooled.
    ARM 1: Kind: Experimental
    Label: 2
    Description: Left Atrial Catheter Ablation
  • Rate control Procedure
    Intervention Desc: Digoxin 0.125mg
    ARM 1: Kind: Experimental
    Label: Pharmacologic Therapy
    Description: 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.
  • Ablation Therapy Device
    Other Names: St. Jude: Livewire
    ARM 1: Kind: Experimental
    Label: Ablation Therapy
    Description: 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.
  • Rhythm Control Procedure
    Intervention Desc: Quinidine 600-900mg
    ARM 1: Kind: Experimental
    Label: Pharmacologic Therapy
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/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 under-treated AF. Trial length Yes
Secondary A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest. Trial length Yes
Secondary Medical costs and resource utilization and cost effectiveness Trial length No
Secondary Composite adverse events Trial length Yes
Secondary 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. Trial length Yes
Secondary Quality of Life 3 months and annual No
Primary Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up 12 months after intervention No

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