Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial (CABANA)
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| ClinicalTrials.gov Identifier: NCT00578617 |
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Recruitment Status :
Completed
First Posted : December 21, 2007
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
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Sponsor:
Mayo Clinic
Collaborators:
Duke Clinical Research Institute
Abbott Medical Devices
Information provided by:
Mayo Clinic
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Arrhythmia | Drug: Rate Control Device: Ablation Therapy Drug: Rate control Drug: Rhythm Control Drug: Rhythm control | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial |
| Study Start Date : | September 2006 |
| Actual Primary Completion Date : | February 2009 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Pharmacologic Therapy
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.
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Drug: Rate Control
Metoprolol 50-100mg
Other Name: Toprol Drug: Rate Control Atenolol 50-100mg,
Other Name: Tenormin Drug: Rate control Propranolol 40-80mg
Other Name: Inderal Drug: Rate control Acebutolol 200mg
Other Name: Sectral Drug: Rate control Carvedilol 6.25mg
Other Name: Coreg Drug: Rate Control Diltiazem 180-240mg
Other Name: Cardizem Drug: Rate Control Verapamil 180-240mg
Other Name: Calan Drug: Rate Control Digoxin 0.125mg
Other Name: Lanoxin Drug: Rhythm Control Propafenone 450mg
Other Name: Rhythmol Drug: Rhythm control Flecainide 200mg
Other Name: Tambacor Drug: Rhythm control Sotalol 240mg
Other Name: Betapace Drug: Rhythm control Dofetilide 500mcg
Other Name: Tykosin Drug: Rhythm control Amiodarone 200mg
Other Name: Cordarone Drug: Rhythm control Quinidine 600-900mg
Other Name: Quini-glute/dex |
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Active Comparator: Ablation Therapy
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.
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Device: Ablation Therapy
Other Name: St. Jude: Livewire |
Primary Outcome Measures :
- Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up [ Time Frame: 12 months after intervention ]Documentation of atrial fibrillation using a cardiac event recorder
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578617
Locations
| United States, Alabama | |
| Universtity of Alabama Hospital | |
| Birminham, Alabama, United States, 35233 | |
| United States, California | |
| Good Samaritan Hospital | |
| Los Angeles, California, United States, 90017 | |
| United States, Illinois | |
| Loyola University | |
| Maywood, Illinois, United States, 60626 | |
| United States, Iowa | |
| Mercy Medical Center | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Brigham and Womens Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55902 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| University of Pennsylvania Health | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
Sponsors and Collaborators
Mayo Clinic
Duke Clinical Research Institute
Abbott Medical Devices
Investigators
| Principal Investigator: | Douglas L. Packer, M.D. | Mayo Clinic |
Additional Information:
Publications:
Publications:
| Responsible Party: | Douglas L. Packer, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00578617 |
| Other Study ID Numbers: |
06-003867 |
| First Posted: | December 21, 2007 Key Record Dates |
| Results First Posted: | January 4, 2013 |
| Last Update Posted: | January 4, 2013 |
| Last Verified: | December 2012 |
Keywords provided by Mayo Clinic:
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Atrial fibrillation Left Atrial Ablation Pulmonary Vein Isolation Catheter Ablation Antiarrhythmic Drug Therapy |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Vasodilator Agents |
Potassium Channel Blockers Membrane Transport Modulators Sodium Channel Blockers Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors |