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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with CelsiusTMDS® 8 mm catheter, until complete isthmic block is achieved.
After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® 3.5 mm catheter of irrigated tip, until complete isthmic block is achieved.
After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® SF catheter, until complete isthmic block is achieved.
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Time to get cavo-tricuspid isthmus block
Time frame: during the ablation.
Time of fluoroscopy.
Time frame: during the ablation.
Radio frequency application time.
Time frame: during the ablation.
Complications.
Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.
Time frame: within the first 24 hours.
Recurrence of atrial flutter.
Time frame: one year.
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