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Botulinum Toxin Injection Into Epicardial Fat Pads to Prevent Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Botulinum Toxin Injection Into Epicardial Fat Pads to Prevent Atrial Fibrillation in Patients Undergoing Cardiac Surgery: Randomized Study

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02617069
Enrollment
170
Registered
2015-11-30
Start date
2015-09-30
Completion date
2018-03-31
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, botulinum toxin

Brief summary

The aim of this prospective randomized double-blind study was to compare the efficacy of botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients undergoing cardiac surgery.

Interventions

BIOLOGICALbotulinum toxin injection
BIOLOGICAL0.9% normal saline injection
DEVICEImplantable loop recorder

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Key inclusion Criteria: * 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 Key

Exclusion criteria

* Planned maze procedure or pulmonary vein isolation

Design outcomes

Primary

MeasureTime frame
Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation (AF) and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug.1 month

Secondary

MeasureTime frame
Recurrence of >30 s of any atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug.12 months

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, Prof, MD, PhD
E.pokushalov@gmail.com+73833327655
Backup ContactMarina Nikitenko
nikitenko.marina.maratovna@gmail.com+73833327655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026