What this study is
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.
What's being tested
- Vacuum Stabilizer System
Intervention · DEVICE
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
- Vacuum Positioner System
Intervention · DEVICE
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
- Blower/Mister
Intervention · DEVICE
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
- Proximal Seal System
Intervention · DEVICE
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
Study details
- 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
- Sponsor
- Maquet Cardiovascular
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Enrolling
- 200 people
- Starts
- 2026-03-04
- Est. completion
- 2026-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openSt. Joseph's Medical Center Stockton
Stockton, California, United States
- Lucas Anderson · Contact
- Mohammad Jamil, MD · Principal investigator
RecruitingAspirus Medical Group
Wausau, Wisconsin, United States
- Jamie Slott · Contact
- Amanda Eilers, MD · Principal investigator
Recruiting
5 sites outside the US
University Medical Center Rostock
Rostock, Germany
- Christian Etz · Contact+49 381 494 6101christian.etz@med.uni-rostock.de
- Professor Dr. Christian Etz · Principal investigator
RecruitingRobert Bosch Gesellschaft für Medizinische Forschung mbH
Stuttgart, Germany
- Dr. Med. Mihnea Ghinescu, Doctor of Medicine · Contact+4917656998964Mihnea.Ghinescu@rbk.de
- Prof. Dr. Adrian Ursulescu · Principal investigator
RecruitingHelios Klinikum Wuppertal GmbH
Wuppertal, Germany
- Sarah Christiani · Contact+49 30 6832 3885sarah.christiani@helios-gesundheit.de
- Kristen Meyers · ContactKirsten.Meyer@helios-gesundheit.de
- Prof. Dr. Mahmoud Diab · Principal investigator
- Dr. M. Amer · Sub-investigator
RecruitingInstitut de Recerca - Hospital Santa Creu i Sant Pau
Barcelona, Spain
- Silvia Herraez Nieto · Contact+34 935 56 56 17SHerraez@santpau.cat
- Dr. Angela Irabien Ortiz, PhD · Principal investigator
- Dr. Antonino José Ginel Iglesias, PhD · Sub-investigator
RecruitingHospital Álvaro Cunqueiro de Vigo
Vigo, Spain
- Laura Sánchez Campaña · Contact+34 986 81 11 11laura.sanchez.campa@gmail.com
- Dr. Juan Jose Legarra Calderon · Principal investigator
Recruiting
Study team
Sponsor
Maquet Cardiovascular
Study ID MCV00110458
Study director
Elizabeth Bulger
Getinge
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.