Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 1

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: endomyocardial BT injection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02002988

BT_PAF01

Details and patient eligibility

About

The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• drug-resistant PAF

Exclusion criteria

• Previous heart surgery and AF ablation procedure
• Emergency CABG
• Unstable angina or heart failure
• Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation)
• Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
• Requiring concomitant valve surgery
• Left ventricle ejection fraction <35%
• Left atrial diameter >55 mm
• Unwillingness to participate

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

BT injection

Experimental group

Treatment:

Procedure: endomyocardial BT injection