First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3)

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if catheter-based atrial fibrillation (AF) ablation is superior to treatment with antiarrhythmic drugs as a first-line therapy for symptomatic persistent AF.

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

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Biosense Webster, Inc.; Texas Cardiac Arrhythmia Research Foundation
• Treatments: Anti-Arrhythmia Agents

Criteria

Inclusion Criteria:

Eligible patients have a history of persistent AF with at least 2 episodes in the 9 months prior to enrollment. Persistent AF is defined according to 2014 AHA/ACC/HRS guidelines as continuous AF that is sustained for more than 7 days.Patients are enrolled if they are:

1. Older than 18.

2. Symptomatic with persistent AF.

3. Experienced at least one AF episode that was documented by surface ECG, 6 months before randomization.

Exclusion Criteria:

1. Documented LVEF <40%.

2. Documented left atrial diameter >/=6cm.

3. Moderate to severe LVH (LV wall thickness >1.5cm).

4. Documented severe valvular disease (aortic stenosis, mitral regurgitation, tricuspid regurgitation or presence of mechanical cardiac valves), active coronary artery disease (defined as the presence of >70% stenosis of coronary arteries or documentation of active myocardial ischemia), recent (within 6 months) CABG.

5. Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.

6. Contraindication for the use of all antiarrhythmic drugs including sotalol, dofetilide, amiodarone 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). [Note: Participants will not be excluded if they are able to take any single or combination of drugs without contraindications]

7. Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.

8. Current enrollment in another investigational drug or device study.

9. 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.

10. Absolute contra-indication to the use of heparin and or oral anticoagulation.

11. Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.

12. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).

13. Documented intra-atrial thrombus, tumor, or another abnormality, which precludes left atrial catheter ablation.

14. Previous use of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine, dofetilide, dronedarone (see below for specifications: Antiarrhythmic Drug Group).

15. Women with a positive pregnancy test.

16. Evidence of active cardiac or systemic infection.

17. Medical condition limiting expected survival to less than one year.