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 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)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
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
Clareo Health | Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
