The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
Atrial Fibrillation, Ischemic Heart Disease
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, botulinum toxin, ischemic heart disease
Eligibility Criteria
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
Sites / Locations
- State Research Institute of Circulation PathologyRecruiting
- Cardiology Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1
Group 2
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
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