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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617069
• Other study ID #: NTPAF-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 25, 2015
• Last updated: September 7, 2017
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Evgeny Pokushalov, Prof, MD, PhD
• Phone: +73833327655
• Email: E.pokushalov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Biological:
• botulinum toxin injection

• 0.9% normal saline injection

Device:
• Implantable loop recorder

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence of >30 s of any atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug.		12 months