Clinical Research Directory

Inclusion Criteria: * Patient is indicated to be treated with the Penditure™ left atrial appendage (LAA) Exclusion System * Greater than or equal to 18 years of age * The subject is willing and able to provide written informed consent and comply with study visit requirements 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)