Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation; Procedure: Linear Lesion Ablation; Drug: BT injection

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02008448

BT_AFPers

Details and patient eligibility

About

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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persistent and longstanding persistent AF

Exclusion criteria

• congestive heart failure
• LV ejection fraction < 35%
• left atrial diameter > 60 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

PVI+LL

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulmonary vein isolation

Procedure: Linear Lesion Ablation

PVI+LL+BT injection

Active Comparator group

Description:

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).

Treatment:

Procedure: Pulmonary vein isolation

Drug: BT injection

Procedure: Linear Lesion Ablation