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Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
endomyocardial BT injection
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BT injection

Arm Description

Outcomes

Primary Outcome Measures

serious adverse events

Secondary Outcome Measures

number of paroxysms

Full Information

First Posted
December 2, 2013
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02002988
Brief Title
Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation
Official Title
Endomyocardial Botulinum Toxin Injection Can Prevent Drug-Resistant Paroxysmal Atrial Fibrillation: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BT injection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
endomyocardial BT injection
Primary Outcome Measure Information:
Title
serious adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
number of paroxysms
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD, FESC
Phone
+79139254858
Email
e.pokushalov@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexander Romanov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Artem Strelnikov, MD

12. IPD Sharing Statement

Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site

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Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

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