Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
(R)-propafenone
Single intravenous dose of (R)-propafenone (2mg/kg) infused over 10 minutes
  • Drug: (R)-propafenone
Active Comparator
(S)-Propafenone
Single intravenous dose of (S)-propafenone (2mg/kg) infused over 10 minutes
  • Drug: (S)-Propafenone
Placebo Comparator
Placebo
Placebo (normal saline) is infused over 10 minutes
  • Drug: Placebo

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232

More Details

NCT ID
NCT02710669
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Diane M Crawford, RN
615-322-3304
diane.m.crawford@vumc.org

Detailed Description

Atrial fibrillation is a common cardiac arrhythmia that needs development of more effective medications. Propafenone is a medicine currently used to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. The investigators have discovered that purified (R)-propafenone may be more effective than (S)-propafenone for treatment of atrial fibrillation, and that (S)-propafenone reduces the efficacy of (R)-propafenone when administered as a mixture. This study will compare the ability of (R)-propafenone, (S)-propafenone, and placebo to suppress the induction of atrial fibrillation in participants undergoing an atrial fibrillation ablation procedure.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.