Atrial Fibrillation, Ischemic Heart Disease
Conditions
Keywords
atrial fibrillation, botulinum toxin, ischemic heart disease
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.
Interventions
DRUGPharmaceutical composition containing botulinum toxin
DRUG0.9% normal saline
PROCEDURECoronary artery bypass grafting
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| number of deaths | 12 month |
| incidence of myocardial infarction | 12 month |
| rehospitalization | 12 months |
| stroke or transient ischemic attack | 12 month |
Countries
Russia
Contacts
Primary ContactAlexander Romanov, MD, PhD
Backup ContactEvgeny Pokushalov, MD, PhD
Outcome results
None listed