Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

Conditions
-----------------
Atrial Fibrillation, Arrhythmia

Intervention / Treatment
-----------------
* Drug: Rate Control
* Device: Ablation Therapy
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacologic Therapy<br>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. | Drug: Rate Control<br>* Metoprolol 50-100mg<br>* Other names: Toprol;Drug: Rate Control<br>* Atenolol 50-100mg,<br>* Other names: Tenormin;Drug: Rate control<br>* Propranolol 40-80mg<br>* Other names: Inderal;Drug: Rate control<br>* Acebutolol 200mg<br>* Other names: Sectral;Drug: Rate control<br>* Carvedilol 6.25mg<br>* Other names: Coreg;Drug: Rate Control<br>* Diltiazem 180-240mg<br>* Other names: Cardizem;Drug: Rate Control<br>* Verapamil 180-240mg<br>* Other names: Calan;Drug: Rate Control<br>* Digoxin 0.125mg<br>* Other names: Lanoxin;Drug: Rhythm Control<br>* Propafenone 450mg<br>* Other names: Rhythmol;Drug: Rhythm control<br>* Flecainide 200mg<br>* Other names: Tambacor;Drug: Rhythm control<br>* Sotalol 240mg<br>* Other names: Betapace;Drug: Rhythm control<br>* Dofetilide 500mcg<br>* Other names: Tykosin;Drug: Rhythm control<br>* Amiodarone 200mg<br>* Other names: Cordarone;Drug: Rhythm control<br>* Quinidine 600-900mg<br>* Other names: Quini-glute/dex;|
| Active Comparator: Ablation Therapy<br>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. | Device: Ablation Therapy<br> <br> * Other names: St. Jude: Livewire;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up | Documentation of atrial fibrillation using a cardiac event recorder | 12 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy