Clinical Trial: Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study

Brief Summary: Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

Detailed Summary:

New porous tip catheters appear more effective in atrial fibrillation ablation than conventional irrigated catheter, with the same safety. We could hypothesize porous tip irrigated catheters are more effective than conventional irrigated catheter, reducing procedure time and RF ablation time.We realize a randomized comparison study.

For that, 70 patients with an indication for isthmus-dependent atrial flutter ablation will be randomized to conventional irrigated catheter ablation or porous tip irrigated catheter ablation. A ECG-Holter examination will be done at 1 month follow up after catheter ablation, 6 and 12 months.


Sponsor: Hospital Clinic of Barcelona

Current Primary Outcome: Time needed to block cavo-tricuspidal isthmus [ Time Frame: During ablation procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiofrequency time. [ Time Frame: During ablation procedure ]
    Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.
  • Fluoroscopy time. [ Time Frame: During ablation procedure. ]
    Total X-ray time needed to achieve CTI block.
  • Complications during the procedure. [ Time Frame: During ablation procedure. ]
  • Survival free from flutter [ Time Frame: Up to 12 months after procedure. ]
    Proportion of patients not presenting with an atrial flutter recurrence.


Original Secondary Outcome: Same as current

Information By: Hospital Clinic of Barcelona

Dates:
Date Received: February 26, 2014
Date Started: November 2012
Date Completion: March 2017
Last Updated: February 24, 2017
Last Verified: February 2017