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
Maquet Cardiovascular
200 participants
Mar 4, 2026
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- ≥ 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 Criteria2
- 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.
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Interventions
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07286890