Back to resultsRadiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter
Primary Purpose
Atrial Flutter
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
radiofrequency ablation
Botulinum Toxin Type A injection
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- ECG documented paroxysmal or persistent AFL
- No prior documented history of AF
- Patient undergoing RFA of AFL.
- No indication (other than AFL) for continued anticoagulation with warfarin.
- No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
Exclusion Criteria:
- A history of atrial fibrillation
- Previous AF ablation procedure
- Congestive heart failure
- Left Ventricle ejection fraction less than 35%
- Unwillingness to participate
Sites / Locations
- State Research Institute of Circulation PathologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
RFA+BT injection
RFA
Arm Description
Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a flow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).
Outcomes
Primary Outcome Measures
number of paroxysms of atrial fibrillation
Secondary Outcome Measures
AF burden
serious adverse events
Full Information
NCT ID
NCT02002962
First Posted
December 2, 2013
Last Updated
September 21, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02002962
Brief Title
Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter
Official Title
Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter to Prevent Post-procedural 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
June 2015 (Actual)
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
Yes
5. Study Description
Brief Summary
The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the radiofrequency ablation of atrial flutter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RFA+BT injection
Arm Type
Active Comparator
Arm Description
Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
Arm Title
RFA
Arm Type
Active Comparator
Arm Description
Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a flow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A injection
Primary Outcome Measure Information:
Title
number of paroxysms of atrial fibrillation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
AF burden
Time Frame
1 year
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:
Age ≥ 18 years
ECG documented paroxysmal or persistent AFL
No prior documented history of AF
Patient undergoing RFA of AFL.
No indication (other than AFL) for continued anticoagulation with warfarin.
No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
Exclusion Criteria:
A history of atrial fibrillation
Previous AF ablation procedure
Congestive heart failure
Left Ventricle ejection fraction less than 35%
Unwillingness to participate
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
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
Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter
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