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

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

Who can join

Ages 22 and older · All sexes

Inclusion Criteria:

* ≥ 22 years of age
* Patient (or a legally authorized representative) is willing and able to provide signed informed consent, if required
* Undergoing planned beating heart coronary artery bypass graft procedure with/without left atrial appendage closure, where the use of at least one Getinge's Beating Heart study product is anticipated.

Exclusion Criteria:

* Patients undergoing heart valve surgery
* Patients who undergo either planned or unplanned conversion to on pump with arrested heart where Getinge's Beating Heart product(s) have not been used.

About the study

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.

What is being tested

• Vacuum Stabilizer System (device)
• Vacuum Positioner System (device)
• Blower/Mister (device)
• Proximal Seal System (device)

Sponsor: Maquet Cardiovascular · Participants: 200 · Started: Mar 4, 2026

Contact the study team

• Sr. Manager, Clinical Affairs · Phone: 603-921-7318

Official record on ClinicalTrials.gov — NCT07286890

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.