NCT07286890 · Maquet Cardiovascular
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
What this study is about
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 the usual treatment.
View original scientific description
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
DEVICE
Vacuum Stabilizer System
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
DEVICE
Vacuum Positioner System
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
DEVICE
Blower/Mister
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
DEVICE
Proximal Seal System
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
Primary outcome measures
Incidence of device-related adverse events
Time frame: 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 frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Stockton, California
- Wausau, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations