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

Supra-ventricular Tachyarrhythmias Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02008461
• Other study ID #: BT_SVT
• Status: Recruiting
• Phase: Phase 2
• First received: December 6, 2013
• Last updated: September 21, 2015
• Start date: June 2013
• Est. completion date: February 2016

Study information

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

Clinical Trial Summary

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome

• secondary atrial fibrillation

Exclusion Criteria:

• congestive heart failure

• LV ejection fraction < 35%

• left atrial diameter > 60 mm

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supra-ventricular Tachyarrhythmias
• Tachycardia, Ventricular

Intervention

Procedure:
• radiofrequency ablation

Drug:
• botulinum toxin injection

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of episodes of atrial fibrillation		1 year	No
Secondary	serious adverse events		1 year	Yes

External Links

•   State Research Institute of Circulation Pathology Official Site