Off Pump Coronary Artery Bypass SurgeryNCT07286890
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
An observational study of Off Pump Coronary Artery Bypass Surgery, run by Maquet Cardiovascular at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Off Pump Coronary Artery Bypass Surgery
- What is being tested?
- Vacuum Stabilizer System, Vacuum Positioner System and Blower/Mister
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 4 Mar 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing beating heart coronary artery bypass surgery where 1 or more Beating Heart study products are used according to the device labeling.
Who may be able to join
- ≥ 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.
Who cannot join
- 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 locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Germany3 sites, 3 recruiting
- Recruiting
University Medical Center Rostock
Rostock
Christian Etz, +49 381 494 6101, christian.etz@med.uni-rostock.de
Professor Dr. Christian Etz
- Recruiting
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Stuttgart, 70376
Dr. Med. Mihnea Ghinescu, Doctor of Medicine, +4917656998964, Mihnea.Ghinescu@rbk.de
Prof. Dr. Adrian Ursulescu
- Recruiting
Helios Klinikum Wuppertal GmbH
Wuppertal, 42283
Sarah Christiani, +49 30 6832 3885, sarah.christiani@helios-gesundheit.de
Kristen Meyers, Kirsten.Meyer@helios-gesundheit.de
United States2 sites, 2 recruiting
- Recruiting
St. Joseph's Medical Center Stockton
Stockton, California, 95204
Lucas Anderson
Mohammad Jamil, MD
- Recruiting
Aspirus Medical Group
Wausau, Wisconsin, 54401
Jamie Slott
Amanda Eilers, MD
Spain2 sites, 2 recruiting
- Recruiting
Institut de Recerca - Hospital Santa Creu i Sant Pau
Barcelona, 08041
Silvia Herraez Nieto, +34 935 56 56 17, SHerraez@santpau.cat
Dr. Angela Irabien Ortiz, PhD
- Recruiting
Hospital Álvaro Cunqueiro de Vigo
Vigo, 36212
Laura Sánchez Campaña, +34 986 81 11 11, laura.sanchez.campa@gmail.com
Dr. Juan Jose Legarra Calderon
About this study
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
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.
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Being tested
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister, Proximal Seal System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Stabilizer SystemDevice
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
Vacuum Positioner SystemDevice
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
Blower/MisterDevice
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
Proximal Seal SystemDevice
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
| Study group | Role | What they receive |
|---|---|---|
| Getinge Beating heart study devices group | Not described Receives: Device: Vacuum Stabilizer System; Device: Vacuum Positioner System; Device: Blower/Mister; Device: Proximal Seal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related adverse events
Incidence of device-related adverse events for each subject
Measured: Time period from procedure through study completion, an average of 7 days
Incidence of device-related serious adverse events
Incidence of device-related serious adverse events experienced by subjects
Measured: Time period from procedure through study completion, an average of 7 days
Incidence of technical success
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.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start4 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off Pump Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Bulger, Study director, Getinge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286890
- Sponsor's protocol ID
- MCV00110458
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07286890
- Acronym / sponsor ID
- MCV00110458
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maquet CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Getinge Beating heart study devices group | – | Device: Vacuum Stabilizer System, Device: Vacuum Positioner System, Device: Blower/Mister, Device: Proximal Seal System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing beating heart coronary artery bypass surgery where 1 or more Beating Heart study products are used according to the device labeling.
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum Stabilizer SystemIsolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart. | Device | Getinge Beating heart study devices group |
| Vacuum Positioner SystemPositions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart. | Device | Getinge Beating heart study devices group |
| Blower/MisterReduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart. | Device | Getinge Beating heart study devices group |
| Proximal Seal SystemProximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures. | Device | Getinge Beating heart study devices group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Bulger study director
Getinge
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Off Pump Coronary Artery Bypass Surgery, run by Maquet Cardiovascular at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sr. Manager, Clinical Affairs (603-921-7318, inka.vesela@getinge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device-related adverse events (time frame: Time period from procedure through study completion, an average of 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.