Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

NCT00578617 | Completed Results DMC

• 1 other identifier: 06-003867
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

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.

Conditions

Atrial Fibrillation; Arrhythmia

Keywords

Atrial fibrillation; Left Atrial Ablation; Pulmonary Vein Isolation; Catheter Ablation; Antiarrhythmic Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pharmacologic Therapy

ACTIVE COMPARATOR

Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug.

Drug: Rate Control; Drug: Rhythm Control

Ablation Therapy

ACTIVE COMPARATOR

Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.

Device: Ablation Therapy

Interventions

Rate Control DRUG

Metoprolol 50-100mg

Also known as: Toprol

Pharmacologic Therapy

Ablation Therapy DEVICE

Also known as: St. Jude: Livewire

Ablation Therapy

Rhythm control DRUG

Propafenone 450mg

Also known as: Rhythmol

Pharmacologic Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Duke Clinical Research Institute: collaborator
• Abbott Medical Devices: collaborator

Study Sites (10)

Universtity of Alabama Hospital

Birminham, Alabama, 35233, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Loyola University

Maywood, Illinois, 60626, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania Health

Philadelphia, Pennsylvania, 19104, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related 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.

  PMID: 20498271 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Heart Rate; Metoprolol; Atenolol; Propranolol; Acebutolol; Carvedilol; Diltiazem; Verapamil; Digoxin; Sotalol; Amiodarone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Benzazepines; Phenethylamines; Ethylamines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Glycosides; Carbohydrates; Ethanolamines; Benzofurans

Limitations and Caveats

Limited number enrolled. Study was designed to demonstrate feasibility for a pivotal trial, but small enrollment limits the final conclusions that can be drawn from a simple 'time to first atrial fibrillation recurrence.'

Results Point of Contact

• Title: Kristi Monahan
• Organization: Mayo Clinic

CABANA@mayo.edu

507-255-6676

Study Officials

• Douglas L. Packer, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 21, 2007
• Study Start: September 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2010
• Last Updated: January 4, 2013
• Results First Posted: January 4, 2013

Record last verified: 2012-12

Locations

US (10)