Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorMaquet Cardiovascular
About this trial
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
Qualifiers
≥ 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vacuum Stabilizer System
- Vacuum Positioner System
- Blower/Mister
- Proximal Seal System
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov