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NCT02002962 Clinical Trial

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

Atrial Flutter Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02002962
Other study ID # BT_AFL
Secondary ID
Status Recruiting
Phase Phase 2
First received December 2, 2013
Last updated September 21, 2015
Start date June 2013
Est. completion date January 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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date January 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• radiofrequency ablation

Drug:
• Botulinum Toxin Type A injection

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of paroxysms of atrial fibrillation 1 year Yes
Secondary AF burden 1 year No
Secondary serious adverse events 1 year Yes
See also
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Completed NCT02810938 - MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology
Recruiting NCT02591875 - Atrial Flutter Ablation in a Real World Population N/A
Completed NCT01914497 - Dipole Density Mapping of Typical Atrial Flutter N/A
Completed NCT02268799 - High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter N/A
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