Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of Circulation Pathology
        • Contact:
          • Evgeny Pokushalov, MD, PhD
        • Sub-Investigator:
          • Artem Strelnikov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BT injection
Procedure: endomyocardial BT injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serious adverse events
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
number of paroxysms
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Evgeny Pokushalov, MD, PhD, State Research Institute of Circulation Pathology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT_PAF01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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