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

Meshalkin Research Institute of Pathology of Circulation170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

170

Conditions

Atrial Fibrillation

Interventions

botulinum toxin injectionBIOLOGICAL

0.9% normal saline injectionBIOLOGICAL

Implantable loop recorderDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, Russia

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

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

Time frame: 12 months

Central Contacts

Evgeny Pokushalov, Prof, MD, PhD

CONTACT

+73833327655 E.pokushalov@gmail.com

Marina Nikitenko

CONTACT

+73833327655 nikitenko.marina.maratovna@gmail.com

Data from ClinicalTrials.gov

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