Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibri... | NCT02002988

Studies
Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

NCT02002988

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown status

Last Update Posted

Sep 23, 2015Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Paroxysmal Atrial Fibrillation

Interventions

endomyocardial BT injection

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Dec 2, 2013

First Submission Date that Met QC Criteria

Dec 2, 2013

First Posted Date

Dec 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
BT injection	Experimental		Procedure: endomyocardial BT injection

Name	Type	Description	Arm Group Labels	Other Names
endomyocardial BT injection	Procedure		BT injection

Measure	Description	Time Frame
serious adverse events		1 year

Measure	Description	Time Frame
number of paroxysms		1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Evgeny Pokushalov, MD, PhD, FESC	Contact	+79139254858		e.pokushalov@gmail.com

Overall Officials

Name	Affiliation	Role
Evgeny Pokushalov, MD, PhD	State Research Institute of Circulation Pathology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State Research Institute of Circulation Pathology	Recruiting	Novosibirsk		630055	Russia

References Module

Citations

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes