The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
Phase 2
- Conditions
- Atrial FibrillationIschemic Heart Disease
- Interventions
- Drug: Pharmaceutical composition containing botulinum toxinDrug: 0.9% normal salineProcedure: Coronary artery bypass grafting
- Registration Number
- NCT02982434
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months)
- At least one failed antiarrhythmic drug
- Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery
Exclusion Criteria
Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Pharmaceutical composition containing botulinum toxin All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP Group 1 Coronary artery bypass grafting All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP Group 2 0.9% normal saline All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP Group 2 Coronary artery bypass grafting All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP
- Primary Outcome Measures
Name Time Method Freedom from any atrial tachyarrhythmias 12 months Recurrence of \>30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
- Secondary Outcome Measures
Name Time Method time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU 1 month incidence of congestive heart failure 12 month incidence of sustained ventricular arrhythmias 12 month stroke or transient ischemic attack 12 month incidence of myocardial infarction 12 month rehospitalization 12 months number of deaths 12 month
Trial Locations
- Locations (2)
Cardiology Research Institute
🇷🇺Tomsk, Russian Federation
State Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation