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Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation

Phase 2
Conditions
Persistent Atrial Fibrillation
Interventions
Procedure: Pulmonary vein isolation
Procedure: Linear Lesion Ablation
Registration Number
NCT02008448
Lead Sponsor
Meshalkin Research Institute of Pathology of Circulation
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
160
Inclusion Criteria
  • Persistent and longstanding persistent AF
Exclusion Criteria
  • congestive heart failure
  • LV ejection fraction < 35%
  • left atrial diameter > 60 mm

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PVI+LL+BT injectionBT injectionCircumferential 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).
PVI+LLPulmonary vein isolationCircumferential 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.
PVI+LLLinear Lesion AblationCircumferential 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.
PVI+LL+BT injectionLinear Lesion AblationCircumferential 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).
PVI+LL+BT injectionPulmonary vein isolationCircumferential 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).
Primary Outcome Measures
NameTimeMethod
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia1 year
Secondary Outcome Measures
NameTimeMethod
serious adverse events1 year

Trial Locations

Locations (2)

University of Rochester

πŸ‡ΊπŸ‡Έ

Rochester, New York, United States

State Research Institute of Circulation Pathology

πŸ‡·πŸ‡Ί

Novosibirsk, Russian Federation

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