CLIP-IT Post-Market Study

exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study

The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.

Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip at up to 25 sites in the United States.

Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.

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)