- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02710669
New Formulations of Propafenone to Treat Atrial Fibrillation
Comparison of (R) and (S) Propafenone for Prevention of Atrial Fibrillation Induction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion:
- History of atrial fibrillation
- Greater than or equal to 18 years of age
- Scheduled to undergo an atrial fibrillation ablation procedure
- Able to provide written informed consent
Exclusion:
- Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)
- Is in atrial fibrillation or atrial flutter the morning of the ablation procedure
The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator
- sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia
- sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration
- right bundle branch block, left bundle branch block, or bifascicular block
- PR-interval > 280ms, or history of 2nd or 3rd degree atrioventricular block
- Concomitant use of CYP3A4 and CYP2D6 inhibitors
- Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure
- Amiodarone use within 3 months prior to enrollment
- Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation
- Expected life span < 1 year
- Creatinine clearance <30 mL/min
- Reversible cause of atrial fibrillation (ie. thyrotoxicosis)
- Unrevascularized coronary artery disease
- Canadian class IV angina
- Left ventricular ejection fraction <40%
- New York Heart Association Class III or IV symptoms
- Previous heart transplantation
- Planned heart transplantation or ventricular assist device
- Cardiac/thoracic surgery <6 months prior to enrollment
- Severe asthma or chronic obstructive pulmonary disease
- Breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: (R)-propafenone
Single intravenous dose of (R)-propafenone (2mg/kg) infused over 10 minutes
|
|
Active Comparator: (S)-Propafenone
Single intravenous dose of (S)-propafenone (2mg/kg) infused over 10 minutes
|
|
Placebo Comparator: Placebo
Placebo (normal saline) is infused over 10 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Successful Induction of 30 Seconds of Atrial Fibrillation/Atrial Flutter
Time Frame: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
|
A rapid atrial pacing protocol was used to attempt to induce atrial fibrillation/atrial flutter.
Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter.
Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms.
Bursts from the CS proximal electrode were induced to attempt atrial fibrillation.
|
Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Successful Inducibility of Atrial Fibrillation/Atrial Flutter Expressed as an Ordinal Variable Based on Stage of the Induction Protocol
Time Frame: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
|
Inducibility of atrial fibrillation (AF) or atrial flutter (AFL) expressed as an ordinal variable based on stage of the induction protocol.
Stage 3 consisted of 15-second bursts. The cycle length used for the bursts was the fastest cycle length achieved during Step 2 that maintained 1:1 atrial conduction. |
Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
|
Number of Participants With Successful Induction of 30 Seconds of Atrial Flutter
Time Frame: Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
|
A rapid atrial pacing protocol was used to attempt to induce atrial flutter.
Twenty minutes after start of the study drug, participants underwent placement of a decapolar coronary sinus catheter.
Pacing was performed from the proximal electrode at 20 milliamps and a pulse width of 2 ms.
Bursts from the CS proximal electrode were induced to attempt atrial flutter.
|
Twenty minutes post-dosage to end of induction protocol (approximately 10 minutes)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bjorn Knollmann, MD/PhD, Vanderbilt University
- Study Director: Ben Shoemaker, MD, Vanderbilt University
Publications and helpful links
General Publications
- Faggioni M, Savio-Galimberti E, Venkataraman R, Hwang HS, Kannankeril PJ, Darbar D, Knollmann BC. Suppression of spontaneous ca elevations prevents atrial fibrillation in calsequestrin 2-null hearts. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):313-20. doi: 10.1161/CIRCEP.113.000994. Epub 2014 Feb 3.
- Shoemaker MB, Yoneda ZT, Crawford DM, Akers WS, Richardson T, Montgomery JA, Phillips S, Shyr Y, Saavedra P, Estrada JC, Kanagasundram A, Shen ST, Michaud GF, Crossley G, Ellis CR, Knollmann BC. A Mechanistic Clinical Trial Using (R)- Versus (S)-Propafenone to Test RyR2 (Ryanodine Receptor) Inhibition for the Prevention of Atrial Fibrillation Induction. Circ Arrhythm Electrophysiol. 2022 Oct;15(10):e010713. doi: 10.1161/CIRCEP.121.010713. Epub 2022 Sep 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 151952
- 1R01HL124935-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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