Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

Atrial Fibrillation Clinical Trial

— CABANA  

Official title:

Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578617
• Other study ID #: 06-003867
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: December 3, 2012
• Start date: September 2006
• Est. completion date: June 2010

Study information

• Verified date: December 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Drug:
• Rate Control
Metoprolol 50-100mg

Device:
• Ablation Therapy

Drug:
• Rate Control
Atenolol 50-100mg,
• Rate control
Propranolol 40-80mg
• Rate control
Acebutolol 200mg
• Rate control
Carvedilol 6.25mg
• Rate Control
Diltiazem 180-240mg
• Rate Control
Verapamil 180-240mg
• Rate Control
Digoxin 0.125mg
• Rhythm Control
Propafenone 450mg
• Rhythm control
Flecainide 200mg
• Rhythm control
Sotalol 240mg
• Rhythm control
Dofetilide 500mcg
• Rhythm control
Amiodarone 200mg
• Rhythm control
Quinidine 600-900mg

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Universtity of Alabama Hospital	Birminham	Alabama
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Mercy Medical Center	Des Moines	Iowa
United States	Good Samaritan Hospital	Los Angeles	California
United States	Loyola University	Maywood	Illinois
United States	Intermountain Medical Center	Murray	Utah
United States	University of Pennsylvania Health	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Duke Clinical Research Institute, St. Jude Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up	Documentation of atrial fibrillation using a cardiac event recorder	12 months after intervention	No

External Links

•   Mayo Clinic Clinical Trials