Atrial Flutter. Clinical Trial
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 Dependent Atrial Flutter
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment