The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982434
• Other study ID #: RSTD_021216
• Status: Recruiting
• Phase: Phase 2
• First received: December 1, 2016
• Last updated: December 1, 2016
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: December 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander Romanov, MD, PhD
• Phone: +73833327655
• Email: abromanov[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with paroxysmal AF (recurrent episodes for at least 2 years, with = 6 episodes over the last 6 months)

• At least one failed antiarrhythmic drug

• 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

Exclusion Criteria:

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Pharmaceutical composition containing botulinum toxin

• 0.9% normal saline

Procedure:
• Coronary artery bypass grafting

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
Russian Federation	Cardiology Research Institute	Tomsk

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	Freedom from any atrial tachyarrhythmias	Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug	12 months	Yes
Secondary	number of deaths		12 month	Yes
Secondary	time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU		1 month	Yes
Secondary	incidence of congestive heart failure		12 month	Yes
Secondary	incidence of sustained ventricular arrhythmias		12 month	Yes
Secondary	stroke or transient ischemic attack		12 month	Yes
Secondary	incidence of myocardial infarction		12 month	Yes
Secondary	rehospitalization		12 months	Yes