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



Status:Active, not recruiting
Conditions:Atrial Fibrillation, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 90
Updated:8/4/2017
Start Date:August 2009
End Date:June 2018

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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.

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.

This study will randomize up to 2200 patients to a strategy of catheter ablation versus
pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics
similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF
warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or
≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5
years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to
assess the impact of treatment.

The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF,
establish the cost and impact of therapy on quality of life and will help determine if AF is
a modifiable risk factor for increased mortality.

Inclusion Criteria:

- Over the preceding 6 months have:

1. ≥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

2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7
days or cardioversion is performed more than 48h after AF onset): or

3. 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) [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, 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.

Exclusion Criteria:

- 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.
We found this trial at
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Ypsilanti, Michigan 48197
Principal Investigator: Timothy Shinn, M.D.
Phone: 734-712-8386
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Moussa Mansour, M.D.
Phone: 617-724-8241
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Gregory Michaud, M.D.
Phone: 617-732-5241
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Paul Mounsey, M.D.
Phone: 919-962-4896
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Alexandru Costea, MD
Phone: 513-558-5089
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Eric Buch, M.D.
Phone: 310-206-2235
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1211 Medical Center Dr
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3181 Southwest Sam Jackson Park Road
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503 494-8311
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Adelaide, South Australia
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Albany, New York 12212
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1120 15th Street
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1501 S Potomac St
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1 Cooper Plaza
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1215 Lee St
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30 Prospect Ave
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2160 South 1st Avenue
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1250 E. Marshall St.
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200 First Street SW
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2315 Stockton Blvd.
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625 South New Ballas Road
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505 Parnassus Ave
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1959 NE Pacific St
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300 Pasteur Dr
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2401 S. 31st Street
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Washington, D.C., District of Columbia 20037
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1 Medical Center Blvd
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