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

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)

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