Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

Detailed Description
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No more available data

Official Title
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Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.

Conditions
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Atrial Flutter

Intervention / Treatment
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* Procedure: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes; age>18 yrs ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter. No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter Patients willing to accept the tests and to follow standard procedures Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment Exclusion Criteria: Atrial fibrillation Any arrhythmia requiring antiarrhythmics in the 6 months post procedure Intra atrial thrombosis NYHA class IV Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month Untreated Wolf Parkinson White syndrome Contraindications to oral anticoagulation Life expectancy < 12 month Major surgery or interventional procedure already planned in the 6 month following ablation Pregnancy or breast-feeding Participation in another study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Cool Flex catheter group<br>Therapy Cool Flex Catheter . No more available data | Procedure: Radiofrequency Ablation<br>* Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentual success of the procedure during the hospitalization | Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus. | Up to 4 days | 
| Percentual success of the procedure at 3 months from procedure | Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus. | 3 months | 
| Percentual success of the procedure at 6 months from procedure | Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure. |  | Up to 4 days; 3-6 month | 
| Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given |  | Up to 4 days | 
| Safety of the procedure | recording of procedure-related complications | Up to 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial flutter