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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Getinge Beating heart study devices group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum Stabilizer System | Device | Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device-related adverse events | Incidence of device-related adverse events for each subject | Time period from procedure through study completion, an average of 7 days |
| Incidence of device-related serious adverse events | Incidence of device-related serious adverse events experienced by subjects | Time period from procedure through study completion, an average of 7 days |
| Incidence of technical success | Incidence of technical success, based on the number of patients who have documented successful use and performance of the study device(s) when used as intended, out of the study population. | Perioperative/Periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing beating heart coronary artery bypass surgery where 1 or more Beating Heart study products are used according to the device labeling.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager, Clinical Affairs | Contact | 603-921-7318 | inka.vesela@getinge.com |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Bulger | Getinge | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Medical Center Stockton | Recruiting | Stockton | California | 95204 | United States |
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| Vacuum Positioner System | Device | Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart. |
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| Blower/Mister | Device | Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart. |
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| Proximal Seal System | Device | Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures. |
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| Aspirus Medical Group | Recruiting | Wausau | Wisconsin | 54401 | United States |
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| Robert Bosch Gesellschaft für Medizinische Forschung mbH | Recruiting | Stuttgart | 70376 | Germany |
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| Helios Klinikum Wuppertal GmbH | Recruiting | Wuppertal | 42283 | Germany |
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| Institut de Recerca - Hospital Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
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| Hospital Álvaro Cunqueiro de Vigo | Recruiting | Vigo | 36212 | Spain |
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