The CTSN Embolic Protection Trial is a study to test a device called the CardioGard Embolic Protection Cannula. This device might help keep high-risk heart surgery patients safe during valve operations. A cannula is a thin tube inserted into the body to deliver or remove fluid. In this study, patients aged 60 and older having valve surgery might be randomly chosen to use either the CardioGard device or the standard cannula.
The study will last about 30 months, and patients will be followed for 12 months after their surgery. Patients will be assigned to a group using a computer system. They will not know if they are in the group using the new device or the standard one. This helps researchers see if the new device is more effective and safe.
- Study lasts 30 months, with 12 months follow-up.
- Participants must be 60 or older and meet specific health criteria.
- Participants are randomly assigned to use either the new device or standard cannula.
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