First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Pulmonary Vein Isolation performed by Catheter Ablation; Conventional Antiarrhythmic Drug Therapy
Intervention description: Ablation will be done to achieve entrance block into all pulmonary veins.; Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF
Intervention MeSH terms: Anti-Arrhythmia Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Paroxysmal; Pulmonary Vein Isolation; Ablation Catheter; Anti-arrhythmic Drug Therapy; First Line Therapy

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 atrial fibrillation not previously treated with therapeutic doses of
      antiarrhythmic drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age > 18 and ≤ 75 years old.

          2. 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 Criteria:

          1. Documented LVEF <40%.

          2. Documented left atrial diameter >5.5cm.

          3. Moderate to severe LVH (LV wall thickness >1.5cm).

          4. 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.

          5. Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug
             therapy after the cardioversion was prescribed.

          6. Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid
             hormone replacement therapy are acceptable.

          7. 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).

          8. Previous left heart ablation procedure, either by surgery or by percutaneous catheter,
             for atrial fibrillation.

          9. Current enrollment in another investigational drug or device study.

         10. 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.

         11. Absolute contra-indication to the use of heparin and or warfarin.

         12. Increase risk of bleeding, current peptic ulceration, proliferative diabetic
             retinopathy, history of severe systemic bleeding, or other history of bleeding
             diathesis or coagulopathy.

         13. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive
             disease (COPD).

         14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes
             catheter introduction.

         15. Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone,
             propafenone, flecainide, sotalol, quinidine.

         16. Pacemaker or Implantable Cardioverter Defibrillator.

         17. Women with a positive pregnancy test.

         18. Evidence of active cardiac or systemic infection.

         19. Medical condition limiting expected survival to less than one year.