The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
NCT ID: NCT02982434
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2016-09-30
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
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
Pharmaceutical composition containing botulinum toxin
Coronary artery bypass grafting
Group 2
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
0.9% normal saline
Coronary artery bypass grafting
Interventions
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Pharmaceutical composition containing botulinum toxin
0.9% normal saline
Coronary artery bypass grafting
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Locations
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State Research Institute of Circulation Pathology
Novosibirsk, , Russia
Cardiology Research Institute
Tomsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Alexander Romanov, MD, PhD
Role: primary
Evgeny Pokushalov, MD, PhD
Role: backup
Boris Kozlov, MD
Role: primary
Other Identifiers
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RSTD_021216
Identifier Type: -
Identifier Source: org_study_id