New Formulations of Propafenone to Treat Atrial Fibrillation

• Status: Terminated
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will randomize participants to (R)-propafenone, (S)-propafenone, or placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Propafenone

Criteria

Inclusion:

1. History of atrial fibrillation

2. Greater than or equal to 18 years of age

3. Scheduled to undergo an atrial fibrillation ablation procedure

4. Able to provide written informed consent

Exclusion:

1. Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)

2. Is in atrial fibrillation or atrial flutter the morning of the ablation procedure

3. The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator

1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia

2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration

3. right bundle branch block, left bundle branch block, or bifascicular block

4. PR-interval > 280ms, or history of 2nd or 3rd degree atrioventricular block

4. Concomitant use of CYP3A4 and CYP2D6 inhibitors

5. Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure

6. Amiodarone use within 3 months prior to enrollment

7. Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation

8. Expected life span < 1 year

9. Creatinine clearance <30 mL/min

10. Reversible cause of atrial fibrillation (ie. thyrotoxicosis)

11. Unrevascularized coronary artery disease

12. Canadian class IV angina

13. Left ventricular ejection fraction <40%

14. New York Heart Association Class III or IV symptoms

15. Previous heart transplantation

16. Planned heart transplantation or ventricular assist device

17. Cardiac/thoracic surgery <6 months prior to enrollment

18. Severe asthma or chronic obstructive pulmonary disease

19. Breastfeeding