Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

NCT ID: NCT02002988

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BT injection

Group Type EXPERIMENTAL

endomyocardial BT injection

Intervention Type PROCEDURE

Interventions

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endomyocardial BT injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* drug-resistant PAF

Exclusion Criteria

* Previous heart surgery and AF ablation procedure
* Emergency CABG
* Unstable angina or heart failure
* Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation)
* Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
* Requiring concomitant valve surgery
* Left ventricle ejection fraction \<35%
* Left atrial diameter \>55 mm
* Unwillingness to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evgeny Pokushalov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State Research Institute of Circulation Pathology

Locations

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State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Evgeny Pokushalov, MD, PhD, FESC

Role: CONTACT

+79139254858

Facility Contacts

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Evgeny Pokushalov, MD, PhD

Role: primary

Related Links

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http://meshalkin.ru

State Research Institute of Circulation Pathology Official Site

Other Identifiers

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BT_PAF01

Identifier Type: -

Identifier Source: org_study_id

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