Canadian Left Atrial Appendage Closure Study (CLASS)

This is an interventional treatment trial for Left Atrial Appendage focused on measuring Percutaneous Occlusion Read More

Inclusion Criteria:

• Subject has a documented history of paroxysmal, persistent or permanent non-valvular atrial fibrillation.
• Subject is able to provide informed consent for the procedure.
• Subject is able to be followed for the duration of the study.
• Patient is able to take aspirin and Clopidogrel. Expected duration of dual antiplatelet therapy of 45 days.
• Patient is not able to tolerate or adhere to the requirements of long term anticoagulation therapy.
• Subject has a CHADS score >/= 1.

Exclusion Criteria:

• The patient is known to have an extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
• The patient's size (i.e., too small for TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• LAA anatomical exclusion (depth <16mm and/or diameter <11mm).
• Patients with recent myocardial infarction, unstable angina, or decompensated congestive heart failure. (Recent is defined as within 180 days of implant date).
• Patients with any type of serious infection less than one month prior to procedure.
• Patient has demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Patient is participating in another investigational drug or device study.
• Subject has an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device.
• Subject had surgical ASD or PFO repair.
• Subject has a moderate to severe aortic or mitral valve stenosis or regurgitation as assessed by the investigator.
• Subject has a planned ablation procedure for atrial fibrillation within 60 days after the Ultrasept LAA closure device implant.
• Subject has a New York Heart Association (NYHA) grade 4.
• Patient has a left ventricular ejection fraction of 20% or less.
• Patient has a life expectancy of less than one year.
• Subject has had a recent major cardiac surgical procedure (recent is defined as within 180 days of implant date).
• Subject is pregnant, breastfeeding, or desires to become pregnant during their first 180 days post-implant.
• Subject has a medical disorder that would interfere with completion or evaluation of clinical study results (for e.g. uncontrolled hypertension, uncontrolled diabetes, renal failure, in situ inferior vena cava filter).
• Patient has an allergy to Nickel.