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NCT02002988 Clinical Trial

Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Endomyocardial Botulinum Toxin Injection Can Prevent Drug-Resistant Paroxysmal Atrial Fibrillation: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02002988
Other study ID # BT_PAF01
Secondary ID
Status Recruiting
Phase Phase 1
First received December 2, 2013
Last updated September 21, 2015
Start date June 2013
Est. completion date June 2016

Study information
Verified date September 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact Evgeny Pokushalov, MD, PhD, FESC
Phone +79139254858
Email e.pokushalov@gmail.com
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• endomyocardial BT injection

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary serious adverse events 1 year Yes
Secondary number of paroxysms 1 year No
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Recruiting NCT05172765 - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF) N/A
Recruiting NCT04529785 - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation N/A
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