Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02008448

Enrollment

160

Registered

2013-12-11

Start date

2013-06-30

Completion date

2016-01-31

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

Persistent Atrial Fibrillation

Brief summary

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. Results were assessed with the use of an implanted monitoring device (IMD).

Interventions

PROCEDUREPulmonary vein isolation

PROCEDURELinear Lesion Ablation

DRUGBT 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

* Persistent and longstanding persistent AF

Exclusion criteria

* congestive heart failure * LV ejection fraction \< 35% * left atrial diameter \> 60 mm

Design outcomes

Primary

Measure	Time frame
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia	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