Clinical trial NCT00578617: Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Official title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmia
Keywords: Atrial fibrillation
Left Atrial Ablation
Pulmonary Vein Isolation
Catheter Ablation
Antiarrhythmic Drug Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Abbott Medical Devices
First posted: 2007-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
timeFrame: 12 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Birminham
country: United States
facility: Universtity of Alabama Hospital
state: Alabama
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Des Moines
country: United States
facility: Mercy Medical Center
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Mayo Clinic
name: Douglas L. Packer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083.