Botulinum Toxin Injection Prevent Paroxysmal Atrial Fibrillation

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02002988

Enrollment

Registered

2013-12-06

Start date

2013-06-30

Completion date

2016-06-30

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

Paroxysmal Atrial Fibrillation

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.

Interventions

PROCEDUREendomyocardial BT injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
serious adverse events	1 year

Secondary

Measure	Time frame
number of paroxysms	1 year

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD, FESC

e.pokushalov@gmail.com+79139254858

Outcome results

None listed

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