Real-World Study of Getinge's Beating Heart Devices in Coronary Artery Bypass Graft Surgery to Evaluate Safety and Performance

What this Trial Is About

This observational study is designed to gather data on the safety and performance of Getinge's Beating Heart product family used during open-heart coronary artery bypass graft (CABG) surgery. The study focuses on patients undergoing off-pump CABG procedures, where the heart continues beating during the surgery. The goal is to monitor how these devices perform in real-world settings without requiring additional study-specific procedures from participants. The study includes the use of several Getinge devices such as the Vacuum Stabilizer System to immobilize the target vessel, the Vacuum Positioner System to position the heart and expose coronary arteries, the Blower/Mister to clear blood for better visibility, and the Proximal Seal System for clampless hemostasis during proximal anastomosis. These devices are used according to standard care during the beating heart coronary artery bypass graft surgery. Participants will have information collected from the time of their surgery until hospital discharge, with no extra procedures required specifically for the study. Researchers will track the incidence of device-related adverse events, serious adverse events, and the technical success of the devices during the perioperative period. The average follow-up time for safety and performance monitoring is about 7 days after the surgery.

Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study