Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Detailed Description
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This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)

Official Title
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Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

Conditions
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Typical Atrial Flutter

Intervention / Treatment
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* Device: Therapy Cool Path Duo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A signed written Informed Consent Presence of typical atrial flutter (cavotricuspid isthmus dependent) If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply. One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months In good physical health 18 years of age or older Agree to comply with follow-up visits and evaluation Exclusion Criteria: Prior typical atrial flutter ablation treatment Pregnancy Atypical flutter or scar flutter(non-isthmus dependent) Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment A recent myocardial infarction within 3 months of the intended procedure date Permanent coronary sinus pacing lead Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant) Evidence of intracardiac thrombus or a history of clotting disorders Participation in another investigational study Cardiac surgery within 1 month of the intended procedure date Allergy or contraindication to Heparin

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br> | Device: Therapy Cool Path Duo<br>* All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. |  | 7 days | 
| Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained. |  | 30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cavo-tricuspid dependent