Back to results

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

Primary Purpose

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Status

Unknown status

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Pulmonary vein isolation

Botulinum Toxin

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Persistent and paroxysmal AF

Exclusion Criteria:

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

Sites / Locations

State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PVI only

PVI+BT injection

Arm Description

Outcomes

Primary Outcome Measures

Freedom of AF or other atrial arrhythmias

Secondary Outcome Measures

serious adverse events

Full Information

NCT ID

NCT02002923

First Posted

December 2, 2013

Last Updated

September 21, 2015

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT02002923

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PVI only

Arm Type

Active Comparator

Arm Title

PVI+BT injection

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Pulmonary vein isolation

Intervention Description

The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin

Intervention Description

Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).

Primary Outcome Measure Information:

Title

Freedom of AF or other atrial arrhythmias

Time Frame

1 year

Secondary Outcome Measure Information:

Title

serious adverse events

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Persistent and paroxysmal AF Exclusion Criteria: congestive heart failure LV ejection fraction < 35% left atrial diameter > 60 mm

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evgeny Pokushalov, MD, PhD

Phone

+79139254858

e.pokushalov@gmail.com

Facility Information:

Facility Name

State Research Institute of Circulation Pathology

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, MD, PhD

Phone

+79139254858

E.Pokushalov@gmail.com

First Name & Middle Initial & Last Name & Degree

Evgeny Pokushalov, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alexander Romanov, MD, PhD

12. IPD Sharing Statement

Links:

URL

http://meshalkin.ru

Description

State Research Institute of Circulation Pathology Official Site

Learn more about this trial

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

We'll reach out to this number within 24 hrs