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

Phase 2

• Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein isolation; Drug: Botulinum Toxin

• Registration Number: NCT02002923
• 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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Persistent and paroxysmal 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

Group	Intervention	Description
PVI only	Pulmonary vein isolation	-
PVI+BT injection	Pulmonary vein isolation	-
PVI+BT injection	Botulinum Toxin	-

Primary Outcome Measures

Name	Time	Method
Freedom of AF or other atrial arrhythmias	1 year

Secondary Outcome Measures

Name	Time	Method
serious adverse events	1 year

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation