Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter

Study Overview
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Brief Summary
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To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.

Detailed Description
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This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.

Official Title
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Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter

Conditions
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Typical Atrial Flutter

Intervention / Treatment
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* Device: Therapy™ Cool Flex™ Irrigated Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A signed written Informed Consent Presence of typical atrial flutter (cavo-tricuspid isthmus dependent) If subjects are receiving anti-arrhythmic 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 Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve Evidence of intra-cardiac thrombus or a history of clotting disorders Participation in another investigational study Cardiac surgery within 1 month prior to 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System | Device: Therapy™ Cool Flex™ Irrigated Ablation System<br>* The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter IBI 1500T9 V1.43 RF Generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure | Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness. | 7 days | 
| Primary Efficacy | Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy | Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures. | 3 months |