Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
Overview
- Phase
- Phase 2
- Intervention
- Pulmonary vein isolation
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
- Last Updated
- 10 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Persistent and longstanding persistent AF
Exclusion Criteria
- •congestive heart failure
- •LV ejection fraction \< 35%
- •left atrial diameter \> 60 mm
Arms & Interventions
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.
Intervention: Pulmonary vein isolation
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.
Intervention: 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).
Intervention: Pulmonary vein isolation
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).
Intervention: 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).
Intervention: BT injection
Outcomes
Primary Outcomes
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
Time Frame: 1 year
Secondary Outcomes
- serious adverse events(1 year)