Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
NCT ID: NCT00578617
Last Updated: 2013-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2006-09-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Rate Control
Metoprolol 50-100mg
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
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.
Ablation Therapy
Interventions
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Rate Control
Metoprolol 50-100mg
Ablation Therapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
Abbott Medical Devices
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Douglas L. Packer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Universtity of Alabama Hospital
Birminham, Alabama, United States
Good Samaritan Hospital
Los Angeles, California, United States
Loyola University
Maywood, Illinois, United States
Mercy Medical Center
Des Moines, Iowa, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Pennsylvania Health
Philadelphia, Pennsylvania, United States
Intermountain Medical Center
Murray, Utah, United States
Countries
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References
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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.
Other Identifiers
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06-003867
Identifier Type: -
Identifier Source: org_study_id
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