Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 09-004616
- Scottsdale/Phoenix, Arizona: 09-004616
NCT ID: NCT00911508
Sponsor Protocol Number: 09-004616
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Over the preceding 6 months have:
- ≥2 paroxysmal (electrocardiographic documentation of at least 1) 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 BP >140/90 mmHg) , Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) , Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or 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 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.
- 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, PCI, or valve or bypass surgery in the preceding 3 months
- Hypertrophic obstructive cardiomyopathy (outflow track)
- Class IV angina or Class IV CHF (including past or planned heart transplantation)
- Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.