Randomized Study of CardioGard Embolic Protection Device Versus Standard Cannula in Patients Aged 60 and Older Undergoing High-Risk Valve Surgery

What this Trial Is About

Researchers are evaluating the CardioGard Embolic Protection Cannula in patients aged 60 and older undergoing different types of high-risk valve surgery, with or without coronary artery bypass grafting CABG. This prospective, multicenter, randomized controlled trial compares the safety and effectiveness of the CardioGard device to a standard aortic cannula during surgery. The study also includes an ancillary sub-study investigating the relationship between sleep disturbances and post-operative delirium in this patient population. Participants are randomly assigned in the operating room to either receive the CardioGard Embolic Protection Cannula, which combines standard blood flow with a suction mechanism to capture debris during surgery, or to a standard aortic cannula chosen by the surgeon. Randomization is stratified by surgical procedure and location. The enrollment period is expected to last 30 months, with follow-up extending for 12 months after the procedure. The ancillary sub-study includes about 300 participants and focuses on sleep patterns before and after surgery. During the study, patients undergo evaluations including neurological assessments, cognitive tests, and monitoring for events like ischemic stroke, acute kidney injury, delirium, and mortality within days and months after surgery. Researchers also track sleep quality and circadian rhythm disruptions using questionnaires and actigraphy. Safety and clinical outcomes are monitored throughout hospitalization and during follow-up visits up to one year. The primary outcomes include stroke, acute kidney injury, death, and delirium occurring shortly after surgery.

CTSN Embolic Protection Trial