Back to resultsEndomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
Primary Purpose
Persistent Atrial Fibrillation
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pulmonary vein isolation
Linear Lesion Ablation
BT injection
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Persistent and longstanding persistent AF
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
PVI+LL
PVI+LL+BT injection
Arm Description
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium. 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
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
Secondary Outcome Measures
serious adverse events
Full Information
NCT ID
NCT02008448
First Posted
December 6, 2013
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02008448
Brief Title
Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
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
January 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, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. 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
Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PVI+LL
Arm Type
Active Comparator
Arm Description
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
Arm Title
PVI+LL+BT injection
Arm Type
Active Comparator
Arm Description
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
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)
Pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
Linear Lesion Ablation
Intervention Type
Drug
Intervention Name(s)
BT injection
Primary Outcome Measure Information:
Title
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
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:
Persistent and longstanding persistent AF
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
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
Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
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