Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Rate control
- Conditions
- Atrial Fibrillation
- Sponsor
- Mayo Clinic
- Enrollment
- 60
- Locations
- 10
- Primary Endpoint
- Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
- Status
- Completed
- Last Updated
- 13 years ago
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.
Investigators
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
Arms & Interventions
Pharmacologic Therapy
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.
Intervention: Rate control
Pharmacologic Therapy
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.
Intervention: Rhythm control
Ablation Therapy
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.
Intervention: Ablation Therapy
Outcomes
Primary Outcomes
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Time Frame: 12 months after intervention
Documentation of atrial fibrillation using a cardiac event recorder