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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Atrial Fibrillation

Treatments: Biological: 0.9% normal saline injection; Device: Implantable loop recorder; Biological: botulinum toxin injection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02617069

NTPAF-01

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Group 1 (Cardiac surgery+botulinum toxin)

Experimental group

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

Treatment:

Device: Implantable loop recorder

Biological: botulinum toxin injection

Group 2 (Cardiac surgery+placebo)

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:

Device: Implantable loop recorder

Biological: 0.9% normal saline injection