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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

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

Study 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

Primary outcome measure(s)

• Incidence of device-related adverse events — Time period from procedure through study completion, an average of 7 days
  Incidence of device-related adverse events for each subject
• Incidence of device-related serious adverse events — Time period from procedure through study completion, an average of 7 days
  Incidence of device-related serious adverse events experienced by subjects
• Incidence of technical success — Perioperative/Periprocedural
  Incidence of technical success, based on the number of patients who have documented successful use and performance of the study device(s) when used as intended, out of the study population.

Trial sites (7)