Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Drug: Botulinum Toxin; Procedure: Pulmonary vein isolation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02002923

BT_AF+PVI

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 treatment strategies, PVI only versus PVI plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after follow-up of at least 1 years 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 paroxysmal 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 only

Active Comparator group

Treatment:

Procedure: Pulmonary vein isolation

PVI+BT injection

Active Comparator group

Treatment:

Procedure: Pulmonary vein isolation

Drug: Botulinum Toxin