Overview
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ LAA Exclusion System in subjects undergoing concomitant cardiac surgery.
Description
Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ 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.
Eligibility
Inclusion Criteria:
- Patient is indicated to be treated with the Penditure™ 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 LAA isolation attempt(s)
- Need for emergent cardiac surgery
- Subject is contraindicated for MDCT and/or TEE
- Life expectancy of less than 12 months
- History of cardiac surgery
- Pericarditis
- Presence of thrombus in the left atrium or 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
- 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)