Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study (NCT07286890) | Clinical Trial Compass
RecruitingNot Applicable
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
United States, Germany, Spain200 participantsStarted 2026-03-04
Plain-language 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
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of device-related adverse events
Timeframe: Time period from procedure through study completion, an average of 7 days
2
Incidence of device-related serious adverse events
Timeframe: Time period from procedure through study completion, an average of 7 days