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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Atrial Flutter.

Intervention / Treatment
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* Device: CelsiusTMDS® 8 mm catheter
* Device: Thermocool® 3.5 mm catheter of irrigated tip
* Device: Thermocool® SF catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic common atrial flutter. Electrocardiographic documentation of common atrial flutter. Exclusion Criteria: Refusal to give consent. Life expectancy less than 6 months. Contraindication for ablation. Previous cavo-tricuspid isthmus ablation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CelsiusTMDS® 8 mm catheter<br>50 patients underwent ablation with CelsiusTMDS® 8 mm catheter. | Device: CelsiusTMDS® 8 mm catheter<br>* 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.<br>|
| Active Comparator: Thermocool® 3.5 mm irrigated catheter<br>50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip. | Device: Thermocool® 3.5 mm catheter of irrigated tip<br>* 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.<br>|
| Experimental: Thermocool® SF catheter<br>50 patients underwent ablation with Thermocool® SF catheter. | Device: Thermocool® SF catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to get cavo-tricuspid isthmus block |  | during the ablation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of fluoroscopy. |  | during the ablation. | 
| Radio frequency application time. |  | during the ablation. | 
| Complications. | Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling. | within the first 24 hours. | 
| Recurrence of atrial flutter. |  | one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial flutter, ablation, Thermocool SF catheter