Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
NCT ID: NCT02008448
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
160 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
DOUBLE
Study Groups
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PVI+LL
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.
Pulmonary vein isolation
Linear Lesion Ablation
PVI+LL+BT injection
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).
Pulmonary vein isolation
Linear Lesion Ablation
BT injection
Interventions
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Pulmonary vein isolation
Linear Lesion Ablation
BT injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm
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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University of Rochester
Rochester, New York, United States
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_AFPers
Identifier Type: -
Identifier Source: org_study_id
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