Clinical Trial: Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flex

Brief Summary: The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

Detailed Summary: No more available data
Sponsor: Ettore Sansavini Health Science Foundation

Current Primary Outcome:

  • Percentual success of the procedure during the hospitalization [ Time Frame: Up to 4 days ]
    Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
  • Percentual success of the procedure at 3 months from procedure [ Time Frame: 3 months ]
    Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
  • Percentual success of the procedure at 6 months from procedure [ Time Frame: 6 months ]
    Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • •Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure. [ Time Frame: Up to 4 days; 3-6 month ]
  • Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given [ Time Frame: Up to 4 days ]
  • Safety of the procedure [ Time Frame: Up to 4 days ]
    recording of procedure-related complications


Original Secondary Outcome: Same as current

Information By: Ettore Sansavini Health Science Foundation

Dates:
Date Received: December 13, 2010
Date Started: November 2010
Date Completion:
Last Updated: September 30, 2016
Last Verified: May 2014