search
Back to results

Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias

Primary Purpose

Supra-ventricular Tachyarrhythmias

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
radiofrequency ablation
botulinum toxin 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 Supra-ventricular Tachyarrhythmias

Eligibility Criteria

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

Inclusion Criteria:

  • atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome
  • secondary atrial fibrillation

Exclusion Criteria:

  • congestive heart failure
  • LV ejection fraction < 35%
  • left atrial diameter > 60 mm

Sites / Locations

  • University of Rochester
  • State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RFA

RFA+BT injection

Arm Description

Mapping and radiofrequency ablation are performed by using standard methods.

Mapping and radiofrequency ablation are performed by using standard methods. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).

Outcomes

Primary Outcome Measures

number of episodes of atrial fibrillation

Secondary Outcome Measures

serious adverse events

Full Information

First Posted
December 6, 2013
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
search

1. Study Identification

Unique Protocol Identification Number
NCT02008461
Brief Title
Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
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
December 2015 (Anticipated)
Study Completion Date
February 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
No

5. Study Description

Brief Summary
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supra-ventricular Tachyarrhythmias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RFA
Arm Type
Active Comparator
Arm Description
Mapping and radiofrequency ablation are performed by using standard methods.
Arm Title
RFA+BT injection
Arm Type
Active Comparator
Arm Description
Mapping and radiofrequency ablation are performed by using standard methods. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Type
Drug
Intervention Name(s)
botulinum toxin injection
Primary Outcome Measure Information:
Title
number of episodes of atrial fibrillation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
serious adverse events
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: atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome secondary atrial fibrillation Exclusion Criteria: congestive heart failure LV ejection fraction < 35% left atrial diameter > 60 mm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evgeny Pokushalov, MD, PhD
Phone
+79139254858
Email
e.pokushalov@gmail.com
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
11528
Country
United States
Individual Site Status
Active, not recruiting
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
Phone
+79139254858
Email
E.Pokushalov@gmail.com
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD

12. IPD Sharing Statement

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

Learn more about this trial

Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias

We'll reach out to this number within 24 hrs