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

Phase 2

• Conditions: Atrial Fibrillation
• Interventions: Biological: 0.9% normal saline injection; Biological: botulinum toxin injection; Device: Implantable loop recorder

• Registration Number: NCT02617069
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Primary Completion: 2016-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-08
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (Cardiac surgery+placebo)	0.9% normal saline injection	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
Group 1 (Cardiac surgery+botulinum toxin)	botulinum toxin injection	All patients underwent conventional cardiac surgery. After the main stage of the surgery 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
Group 1 (Cardiac surgery+botulinum toxin)	Implantable loop recorder	All patients underwent conventional cardiac surgery. After the main stage of the surgery 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
Group 2 (Cardiac surgery+placebo)	Implantable loop recorder	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation; 🇷🇺 Novosibirsk, Russian Federation