Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- 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
- Persistent and longstanding persistent AF
- congestive heart failure
- LV ejection fraction < 35%
- left atrial diameter > 60 mm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PVI+LL+BT injection 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). PVI+LL Pulmonary vein isolation 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. PVI+LL Linear Lesion Ablation 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. PVI+LL+BT injection Linear Lesion Ablation 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). PVI+LL+BT injection Pulmonary vein isolation 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).
- Primary Outcome Measures
Name Time Method freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia 1 year
- Secondary Outcome Measures
Name Time Method serious adverse events 1 year
Trial Locations
- Locations (2)
University of Rochester
πΊπΈRochester, New York, United States
State Research Institute of Circulation Pathology
π·πΊNovosibirsk, Russian Federation