Clinical Trial: Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation

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

Official Title: Comparative Study to Assess Safety and Efficacy of Catheters CelsiusTMDS® 8 mm, Thermocool® 3.5 mm of Irrigated Tip and Thermocool® SF in the Treatment of Cavo-tricuspid Isthmus Depende

Brief Summary: The purpose of this study is to determine whether the Thermocool SF ® system is at least as effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of cavo-tricuspid isthmus dependent atrial flutter.

Detailed Summary:

The catheter of Biosense Webster Thermocool SF® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. This allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. There is evidence of greater efficiency of Thermocool SF® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter.

Investigators hypothesize that the Thermocool SF® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters.

150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with CelsiusTMDS® 8 mm, 3.5 mm irrigated tip Thermocool® or Thermocool® SF respectively. After the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ECG-Holter examination at the first and 6th month and monthly phone consultation. Rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.


Sponsor: Hospital Universitario Central de Asturias

Current Primary Outcome: Time to get cavo-tricuspid isthmus block [ Time Frame: during the ablation. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time of fluoroscopy. [ Time Frame: during the ablation. ]
  • Radio frequency application time. [ Time Frame: during the ablation. ]
  • Complications. [ Time Frame: within the first 24 hours. ]
    Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.
  • Recurrence of atrial flutter. [ Time Frame: one year. ]


Original Secondary Outcome: Same as current

Information By: Hospital Universitario Central de Asturias

Dates:
Date Received: February 29, 2016
Date Started: January 2012
Date Completion: December 2016
Last Updated: March 2, 2016
Last Verified: February 2016