First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborator: Johnson & Johnson
• Treatments: Anti-Arrhythmia Agents

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.