Status:
COMPLETED
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent at...
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is estimated to affect 2.2 million people in the United States. AF is a major cause of stroke, adversely aff...
Eligibility Criteria
Inclusion
- Age \> 18 and ≤ 75 years old.
- Symptomatic, recurrent paroxysmal AF lasting \> 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter,12-lead ECG, event monitor or rhythm strip.
Exclusion
- Documented LVEF \<40%.
- Documented left atrial diameter \>5.5cm.
- Moderate to severe LVH (LV wall thickness \>1.5cm).
- Documented valvular disease, coronary heart disease (defined as the presence of \>70% stenosis of coronary arteries or documentation of active myocardial ischemia), post-CABG, postoperative cardiac surgery or peripheral artery disease.
- Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug therapy after the cardioversion was prescribed.
- Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
- Contraindication for the use of sotalol, dofetilide and 1C antiarrhythmic drugs(liver enzymes and serum creatinine that are outside the upper normal lab values, e.g. \> 3 times ULN with 2 abnormal lab values).
- Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.
- Current enrollment in another investigational drug or device study.
- Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period.
- Absolute contra-indication to the use of heparin and or warfarin.
- Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).
- Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction.
- Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine.
- Pacemaker or Implantable Cardioverter Defibrillator.
- Women with a positive pregnancy test.
- Evidence of active cardiac or systemic infection.
- Medical condition limiting expected survival to less than one year.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00392054
Start Date
August 1 2006
End Date
February 1 2012
Last Update
January 31 2020
Active Locations (16)
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1
Texas Cardiac Arrhythmia Foundation
Austin, Texas, United States, 78705
2
Austin Heart
Austin, Texas, United States, 78756
3
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada, V8R 4R2
4
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2