Endomyocardial Botulinum Toxin Injection Can Prevent Drug-Resistant Paroxysmal Atrial Fibrillation: Pilot Study

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country30 target enrollmentJune 2013

ConditionsParoxysmal Atrial Fibrillation

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 30
Locations: 1
Primary Endpoint: serious adverse events
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

June 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

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