Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) 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
| Condition(s) | Off Pump Coronary Artery Bypass Surgery |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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. |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Maquet Cardiovascular |
| Locations | Stockton, California, United States; Wausau, Wisconsin, United States; Stuttgart, Germany; Wuppertal, Germany; Barcelona, Spain; Vigo, Spain |
| Start date | 2026-03-04 |
| NCT ID | NCT07286890 |
| Official listing | https://clinicaltrials.gov/study/NCT07286890 |