Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

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

Detailed Description
-----------------
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.

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

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: Atrial flutter irrigated catheter
* Device: Atrial flutter porous tip catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergone to cti-dependent atrial flutter ablation. Exclusion Criteria: Left atrial flutter or atrial fibrillation Femoral venous access not available. Anticoagulation not therapeutic in patients at high thrombo-embolic risk Other contraindications to radiofrequency ablations: pregnancy, malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atrial flutter, irrigated catheter<br>Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter | Device: Atrial flutter irrigated catheter<br>* A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with conventional irrigated Thermocool® (Biosense Webster, Diamond Bar, CA) catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation<br>|
| Experimental: Atrial flutter, porous tip catheter<br>Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter | Device: Atrial flutter porous tip catheter<br>* A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with Porous tip Thermocool® SF(Biosense Webster, Diamond Bar, CA)irrigated catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to block cavo-tricuspidal isthmus |  | During ablation procedure | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial flutter, Thermocool catheter, Thermocool SF catheter