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

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.

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