Follow-up of Getinge Beating Heart devices after off-pump coronary bypass
Official title: A Real-World Post-Market Clinical Follow-Up Study to Evaluate the Safety and Performance of Getinge's Beating Heart Product Family in Patients Undergoing Beating Heart Coronary Artery Bypass Graft Surgery
Run by Maquet Cardiovascular · NCT07286890 · Data updated 2026-11-12
We will collect information on how Getinge's Beating Heart surgical devices perform and how safe they are for adults having off-pump coronary artery bypass surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Maquet Cardiovascular Industry-sponsored |
| Locations | 7 sites (Stockton, California and 6 other locations) |
| Status | Recruiting |
| Started | March 4, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07286890 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22 or older scheduled for planned off-pump coronary artery bypass grafting where the surgical team anticipates using at least one Getinge Beating Heart product and who can provide informed consent are eligible.
✕Probably not a fit
Patients having valve surgery, or those who are converted to on-pump surgery without having used the Getinge devices, and people under 22 are unlikely to benefit from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational post-market follow-up collects real-world performance and safety data on Getinge's Beating Heart device family used during planned off-pump coronary artery bypass grafting. Use of the vacuum stabilizer, vacuum positioner, blower/mister, or proximal seal system will follow routine surgical care with no study-specific procedures required. Clinical and device-related information is recorded up until hospital discharge after surgery, and patients are eligible if they are at least 22 years old and expected to receive at least one of the devices. Patients undergoing valve surgery or those converted to on-pump without device use are excluded, and enrollment is limited to participating sites in Stockton, CA and Wausau, WI.
Why it matters
Potential benefit: If successful, the study could improve understanding of device safety and inform safer use of these devices in routine off-pump bypass surgeries.
How similar studies have gone: Post-market clinical follow-ups are commonly used for surgical devices to monitor real-world safety and have provided useful safety signals in similar settings, though randomized comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
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St. Joseph's Medical Center Stockton
Stockton, California, United States Recruiting -
Aspirus Medical Group
Wausau, Wisconsin, United States Recruiting -
University Medical Center Rostock
Rostock, Germany Recruiting -
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Stuttgart, Germany Recruiting -
Helios Klinikum Wuppertal GmbH
Wuppertal, Germany Recruiting -
Institut de Recerca - Hospital Santa Creu i Sant Pau
Barcelona, Spain Recruiting
Show 1 more location
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Hospital Álvaro Cunqueiro de Vigo
Vigo, Spain Recruiting
Study contacts
- Study coordinator: Sr. Manager, Clinical Affairs
- Email: inka.vesela@getinge.com
- Phone: 603-921-7318
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This tests whether a 'no-touch' way of handling the ascending aorta during minimally invasive coronary bypass keeps bypass grafts open as well as conventional off-pump bypass for people who need coronary artery bypass surgery.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.