In This SectionTexas Health Research & Education Institute
Disease or Condition
Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction with EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter
The purpose of this study is to demonstrate that the use of EnSite Velocity Contact Technology in conjunction with the Contact Therapy Cool Path ablation catheter for the treatment of typical atrial flutter: (a) does not result into an unacceptable risk of intra-procedural composite serious adverse events; and (b) does not affect efficacy of the ablation procedure.
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.
18 years of age or older.
Agree to comply with follow-up visits and evaluation.
Prior typical atrial flutter ablation treatment.
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
Permanent coronary sinus pacing lead.
Clinically significant Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve.
Evidence of intracardiac thrombus or a history of clotting disorders.
Participation in another investigational study.
Cardiac surgery within 1 month prior to the intended procedure date.