A Real-World Post-Market Clinical Follow-Up Study to Evaluate the Safety and Performance of Getinge's Beating Heart Product Family in Patients Undergoing Beating Heart Coronary Artery Bypass Graft Surgery

Summary

This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery. The surgery and the use of the study devices will be done according to the standard of care. Participants will not be required to undergo any study-specific procedures, and information will be collected only until hospital discharge following the surgery.

Eligibility

Age range

22+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Vacuum Stabilizer System

  Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.

• Device
  Vacuum Positioner System

  Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.

• Device
  Blower/Mister

  Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.

• Device
  Proximal Seal System

  Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.

Locations (2)