CLIP-IT Post-Market Study

Exclusion Criteria

• •Prior left atrial appendage (LAA) isolation attempt(s)
• •Need for emergent cardiac surgery
• •Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE)
• •Life expectancy of less than 12 months
• •History of cardiac surgery
• •Pericarditis
• •Presence of thrombus in the left atrium or left atrial appendage (LAA), prior to or during the procedure
• •Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest
• •Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment
• •Ejection fraction less than 30%
• •Chronic Kidney Disease Stage IV or V (estimated glomerular filtration rate (eGFR) \<30 ml/min)
• •New York Heart Association (NYHA) Class IV heart failure symptoms
• •Patient has a documented history of substance (drug or alcohol) abuse
• •Known allergy to device components (Nickel and/or Titanium)
• •In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions
• •Currently participating in an investigational drug or another device trial or study (excluding registries)