The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Ischemic Heart Disease; Atrial Fibrillation

Treatments: Drug: 0.9% normal saline; Drug: Pharmaceutical composition containing botulinum toxin; Procedure: Coronary artery bypass grafting

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02982434

RSTD_021216

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Group 1

Experimental group

Description:

All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing 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

Treatment:

Procedure: Coronary artery bypass grafting

Drug: Pharmaceutical composition containing botulinum toxin

Group 2

Active Comparator group

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

Treatment:

Drug: 0.9% normal saline

Procedure: Coronary artery bypass grafting