Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
Recruiting now
Conditions studied: Off Pump Coronary Artery Bypass Surgery
In brief
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.
Key facts
- Study ID
- NCT07286890
- Run by
- Maquet Cardiovascular
- People needed
- 200
- Starts
- 2026-03-04
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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.
You may not qualify if…
- 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.
Where it is running
- St. Joseph's Medical Center Stockton — Stockton, California, United States (enrolling)
- Aspirus Medical Group — Wausau, Wisconsin, United States (enrolling)
- Robert Bosch Gesellschaft für Medizinische Forschung mbH — Stuttgart, Germany (enrolling)
- Helios Klinikum Wuppertal GmbH — Wuppertal, Germany (enrolling)
- Institut de Recerca - Hospital Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
- Hospital Álvaro Cunqueiro de Vigo — Vigo, Spain (enrolling)
Full record on ClinicalTrials.gov
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