Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter

Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter to Prevent Post-procedural Atrial Fibrillation

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02002962

Enrollment

Registered

2013-12-06

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

Atrial Flutter

Brief summary

The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the radiofrequency ablation of atrial flutter.

Interventions

PROCEDUREradiofrequency ablation

DRUGBotulinum Toxin Type A injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years * ECG documented paroxysmal or persistent AFL * No prior documented history of AF * Patient undergoing RFA of AFL. * No indication (other than AFL) for continued anticoagulation with warfarin. * No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)

Exclusion criteria

* A history of atrial fibrillation * Previous AF ablation procedure * Congestive heart failure * Left Ventricle ejection fraction less than 35% * Unwillingness to participate

Design outcomes

Primary

Measure	Time frame
number of paroxysms of atrial fibrillation	1 year

Secondary

Measure	Time frame
AF burden	1 year
serious adverse events	1 year

Countries

Russia

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD

e.pokushalov@gmail.com+79139254858

Outcome results

None listed

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