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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00578617
Other study ID # 06-003867
Secondary ID
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


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
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