Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Arrhythmia

In brief

The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.

Key facts

Study ID

NCT00911508

Run by

Mayo Clinic

People needed

2204

Starts

2009-11-13

Expected to finish

2017-12-31

Last updated by the study team

2021-04-21

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Over the preceding 6 months have:
• ≥2 paroxysmal (electrocardiographic documentation of at least 1) atrial fibrillation (AF) episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
• electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
• electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year).
• Warrant active therapy (within the past 3 months) beyond simple ongoing observation
• Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs.
• Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a blood pressure >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, transient ischemic attack or systemic emboli, Atherosclerotic vascular disease (previous myocardial infarction (MI), peripheral arterial disease or aortic plaque), left atrial (LA) size >5.0 cm (or volume index ≥40 cc/m2), or ejection fraction (EF) ≤35.
• Have the capacity to understand and sign an informed consent form.
• Be ≥18 years of age.
• NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or left ventricular (LV) hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.

You may not qualify if…

• Lone AF in the absence of risk factors for stroke in patients <65 years of age
• Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
• Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2)
• An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time
• Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
• Recent cardiac events including MI, percutaneous intervention (PCI), or valve or bypass surgery in the preceding 3 months
• Hypertrophic obstructive cardiomyopathy (outflow track)
• Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation)
• Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. ventricular tachycardia (VT), ventricular fibrillation (VF))
• Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
• Prior LA catheter ablation with the intention of treating AF
• Prior surgical interventions for AF such as the MAZE procedure
• Prior AV nodal ablation
• Patients with other arrhythmias requiring ablative therapy
• Contraindication to appropriate anti-coagulation therapy
• Renal failure requiring dialysis
• Medical conditions limiting expected survival to <1 year
• Women of childbearing potential (unless post-menopausal or surgically sterile)
• Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center)
• Unable to give informed consent
• NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.

Where it is running

• Good Samaritan Hospital — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California at San Francisco Medical Center — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Penrose Saint Francis Health Services — Colorado Springs, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Miami Hospital — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Northside Hospital and Heart Institute — St. Petersburg, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Florida Heart Rhythm-University of South Florida College of Medicine — Tampa, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• Georgia Arrhythmia Consultants & Research Institute — Macon, Georgia, United States
• Alexian Brothers Medical Center — Barrington, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Mercy Medical Center-Iowa Heart Center — West Des Moines, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• Arkansas Cardiology, PA — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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