Clinical Trials/NCT02002923

NCT02002923

Unknown

Phase 2

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

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country160 target enrollmentJune 2013

ConditionsParoxysmal Atrial Fibrillation Persistent Atrial Fibrillation

InterventionsPulmonary vein isolation Botulinum Toxin

DrugsBotulinum Toxin

Overview

Phase: Phase 2
Intervention: Pulmonary vein isolation
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 160
Locations: 1
Primary Endpoint: Freedom of AF or other atrial arrhythmias
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Persistent and paroxysmal AF

Exclusion Criteria

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

Arms & Interventions

PVI only

Intervention: Pulmonary vein isolation

PVI+BT injection

Intervention: Pulmonary vein isolation

PVI+BT injection

Intervention: Botulinum Toxin

Outcomes

Primary Outcomes

Freedom of AF or other atrial arrhythmias

Time Frame: 1 year

Secondary Outcomes

serious adverse events(1 year)

Study Sites (1)

Loading locations...

Similar Trials

Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular TachyarrythmiasSupra-ventricular Tachyarrhythmias

NCT02008461Meshalkin Research Institute of Pathology of Circulation60

Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial FibrillationPersistent Atrial Fibrillation

NCT02008448Meshalkin Research Institute of Pathology of Circulation160

PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)Atrial Fibrillation

NCT00774566Staedtisches Klinikum Karlsruhe322

Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)Persistent Atrial Fibrillation

NCT03053570China Cardiometabolic Registries200

Study Comparing Pulmonary Vein Isolation With the Cryoballoon, Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF)Atrial Fibrillation

NCT01038115Barts & The London NHS Trust237