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

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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