Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

Phase 1

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: endomyocardial BT injection

• Registration Number: NCT02002988
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BT injection	endomyocardial BT injection	-

Primary Outcome Measures

Name	Time	Method
serious adverse events	1 year

Secondary Outcome Measures

Name	Time	Method
number of paroxysms	1 year

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation