A Phase 2 interventional study of Pharmaceutical composition containing botulinum toxin and 0.9% normal saline in Atrial Fibrillation and Ischemic Heart Disease, sponsored by Meshalkin Research Institute of Pathology of Circulation. Status unknown at 2 sites in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-05.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Phase 2, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 180 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
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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
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
Drug: Pharmaceutical composition containing botulinum toxin · Procedure: 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
Drug: 0.9% normal saline · Procedure: Coronary artery bypass grafting
Freedom from any atrial tachyarrhythmias
Recurrence of \>30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
Time frame: 12 months
number of deaths
Time frame: 12 month
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
Time frame: 1 month
incidence of congestive heart failure
Time frame: 12 month
incidence of sustained ventricular arrhythmias
Time frame: 12 month
stroke or transient ischemic attack
Time frame: 12 month
incidence of myocardial infarction
Time frame: 12 month
rehospitalization
Time frame: 12 months
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Meshalkin Research Institute of Pathology of Circulation