Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter
NCT ID: NCT02002962
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RFA+BT injection
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).
radiofrequency ablation
Botulinum Toxin Type A injection
RFA
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).
radiofrequency ablation
Interventions
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radiofrequency ablation
Botulinum Toxin Type A injection
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous AF ablation procedure
* Congestive heart failure
* Left Ventricle ejection fraction less than 35%
* Unwillingness to participate
18 Years
70 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Locations
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State Research Institute of Circulation Pathology
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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State Research Institute of Circulation Pathology Official Site
Other Identifiers
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BT_AFL
Identifier Type: -
Identifier Source: org_study_id
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