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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Meshalkin Research Institute of Pathology of Circulation

Current Primary Outcome: number of paroxysms of atrial fibrillation [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • AF burden [ Time Frame: 1 year ]
  • serious adverse events [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Meshalkin Research Institute of Pathology of Circulation

Dates:
Date Received: December 2, 2013
Date Started: June 2013
Date Completion: January 2016
Last Updated: September 21, 2015
Last Verified: September 2015