Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrhythmia
• Interventions: Drug: Rate control; Device: Ablation Therapy; Drug: Rhythm control

• Registration Number: NCT00578617
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2009-02
• Study Completion: 2010-06
• Results First Submitted: 2011-07-20
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Results First Posted: 2013-01-04
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacologic Therapy	Rate control	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.
Pharmacologic Therapy	Rhythm control	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	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up	12 months after intervention	Documentation of atrial fibrillation using a cardiac event recorder

Trial Locations

Locations (10)

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

Loyola University; 🇺🇸 Maywood, Illinois, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pennsylvania Health; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Universtity of Alabama Hospital; 🇺🇸 Birminham, Alabama, United States

Mercy Medical Center; 🇺🇸 Des Moines, Iowa, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States