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

Sponsors

Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Source 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.

Overall Status Unknown status
Start Date September 2015
Completion Date March 2018
Primary Completion Date March 2016
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time 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 Outcome
Measure Time 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
Enrollment 170
Condition
Intervention

Intervention Type: Biological

Intervention Name: botulinum toxin injection

Arm Group Label: Group 1 (Cardiac surgery+botulinum toxin)

Intervention Type: Biological

Intervention Name: 0.9% normal saline injection

Arm Group Label: Group 2 (Cardiac surgery+placebo)

Intervention Type: Device

Intervention Name: Implantable loop recorder

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Contact

Last Name: Evgeny Pokushalov, Prof, MD, PhD

Phone: +73833327655

Email: [email protected]

Location
Facility: Status: Contact: Investigator: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Evgeny Pokushalov, MD, PhD +79139254858 [email protected] Evgeny Pokushalov, MD, PhD Principal Investigator Alexander Romanov, MD, PhD Sub-Investigator Denis Losik Sub-Investigator
Location Countries

Russian Federation

Verification Date

September 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group 1 (Cardiac surgery+botulinum toxin)

Type: Experimental

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

Label: Group 2 (Cardiac surgery+placebo)

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov