Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
