Overview

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

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Treatments:
Botulinum Toxins
Criteria
Inclusion Criteria:

- Persistent and paroxysmal AF

Exclusion Criteria:

- congestive heart failure

- LV ejection fraction < 35%

- left atrial diameter > 60 mm