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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

botulinum toxin injection

0.9% normal saline injection

Implantable loop recorder

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, botulinum toxin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

State Research Institute of CIrculation Pathology Novosibirsk, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (Cardiac surgery+botulinum toxin)

Group 2 (Cardiac surgery+placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02617069

First Posted

November 25, 2015

Last Updated

September 7, 2017

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT02617069

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial fibrillation, botulinum toxin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (Cardiac surgery+botulinum toxin)

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2 (Cardiac surgery+placebo)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

botulinum toxin injection

Intervention Type

Biological

Intervention Name(s)

0.9% normal saline injection

Intervention Type

Device

Intervention Name(s)

Implantable loop recorder

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evgeny Pokushalov, Prof, MD, PhD

Phone

+73833327655

Email

E.pokushalov@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Nikitenko

Phone

+73833327655

Email

nikitenko.marina.maratovna@gmail.com

Facility Information:

Facility Name

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, MD, PhD

Phone

+79139254858

Email

E.Pokushalov@gmail.com

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alexander Romanov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Denis Losik

Atrial Fibrillation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial