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

NCT02617069 | Unknown Phase 2 DMC

• 1 other identifier: NTPAF-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recurrence of >30 s of any atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug.

  12 months

Study Arms (2)

Group 1 (Cardiac surgery+botulinum toxin)

EXPERIMENTAL

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

Biological: botulinum toxin injection; Device: Implantable loop recorder

Group 2 (Cardiac surgery+placebo)

ACTIVE COMPARATOR

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

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

Interventions

botulinum toxin injection BIOLOGICAL

Group 1 (Cardiac surgery+botulinum toxin)

0.9% normal saline injection BIOLOGICAL

Group 2 (Cardiac surgery+placebo)

Implantable loop recorder DEVICE

Group 1 (Cardiac surgery+botulinum toxin); Group 2 (Cardiac surgery+placebo)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Planned maze procedure or pulmonary vein isolation

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Botulinum Toxins; Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Evgeny Pokushalov, Prof, MD, PhD

CONTACT

+73833327655; E.pokushalov@gmail.com

Marina Nikitenko

CONTACT

+73833327655; nikitenko.marina.maratovna@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: November 30, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2018
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

RU (1)