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Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
Sponsor: Maquet Cardiovascular
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.
Official title: 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
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-03-04
Completion Date
2026-12
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
St. Joseph's Medical Center Stockton
Stockton, California, United States
Aspirus Medical Group
Wausau, Wisconsin, United States