NCT07286890Recruiting
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
Maquet Cardiovascular
Start Date
3/4/2026
Completion Date
12/1/2026
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 Criteria
Age Range: 22 years to No maximum
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.
Interventions
DEVICE
Vacuum Stabilizer System
DEVICE
Vacuum Positioner System
DEVICE
Blower/Mister
DEVICE
Proximal Seal System
Conditions
Off Pump Coronary Artery Bypass Surgery
Locations
St. Joseph's Medical Center Stockton
Stockton, California 95204
United States
Aspirus Medical Group
Wausau, Wisconsin 54401
United States
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Stuttgart, 70376
Germany
Helios Klinikum Wuppertal GmbH
Wuppertal, 42283
Germany
Institut de Recerca - Hospital Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital Álvaro Cunqueiro de Vigo
Vigo, 36212
Spain