The CLIP-IT Post-Market Study is designed to gather information about the Penditure™ LAA Exclusion System, a device used during heart surgery. This is a post-market study, meaning it checks how well the device works after it has been sold. The study will take place at multiple locations in the United States and will involve up to 150 patients. Participants will have the device placed during their heart surgery and will be checked at 30 days, 3 months, 12 months, and once a year for three years.
Key Points:
- Study Length: Participants will be followed for up to 36 months.
- Visits: Regular follow-ups are needed at specific times after surgery.
- Eligibility: Must be 18 or older, need the device, and agree to study rules.
In order to join, you must be at least 18 years old and need the Penditure™ LAA Exclusion System. You cannot join if you have had certain heart treatments before or have serious health issues like kidney disease or heart failure. Participants must be able to attend follow-up visits and agree to the study terms.