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

Mayo Clinic

Status: Completed

Conditions: Arrhythmia; Atrial Fibrillation

Treatments: Drug: Rhythm Control; Drug: Rate Control; Device: Ablation Therapy; Drug: Rhythm control; Drug: Rate control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00578617

06-003867

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pharmacologic Therapy

Active Comparator group

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.

Treatment:

Drug: Rate Control

Drug: Rhythm Control

Drug: Rate Control

Drug: Rate Control

Drug: Rate Control

Drug: Rate Control

Ablation Therapy

Active Comparator group

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.

Treatment:

Device: Ablation Therapy