Off Pump Coronary Artery Bypass Surgery
Conditions
Brief 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.
Interventions
DEVICEVacuum Stabilizer System
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
DEVICEVacuum Positioner System
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
DEVICEBlower/Mister
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
DEVICEProximal Seal System
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
Sponsors
Maquet Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device-related adverse events | Time period from procedure through study completion, an average of 7 days | Incidence of device-related adverse events for each subject |
| Incidence of device-related serious adverse events | Time period from procedure through study completion, an average of 7 days | Incidence of device-related serious adverse events experienced by subjects |
| Incidence of technical success | Perioperative/Periprocedural | 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. |
Countries
Germany, Spain, United States
Contacts
CONTACTSr. Manager, Clinical Affairs
STUDY_DIRECTORElizabeth Bulger
Getinge
Outcome results
None listed