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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02008461

Enrollment

Registered

2013-12-11

Start date

2013-06-30

Completion date

2016-02-29

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supra-ventricular Tachyarrhythmias

Brief 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).

Interventions

PROCEDUREradiofrequency ablation

DRUGbotulinum toxin injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of episodes of atrial fibrillation	1 year

Secondary

Measure	Time frame
serious adverse events	1 year

Countries

Russia, United States

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD

e.pokushalov@gmail.com+79139254858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026