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โ† Trials
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Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study

Recruitingn/aAges 22 Years - anyAllMaquet Cardiovascular
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ 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.
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What it tests

  • Vacuum Stabilizer System
  • Vacuum Positioner System
  • Blower/Mister
  • Proximal Seal System
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Where

7 sites
St. Joseph's Medical Center Stockton
Stockton, United States
Aspirus Medical Group
Wausau, United States
University Medical Center Rostock
Rostock, Germany
Robert Bosch Gesellschaft fรผr Medizinische Forschung mbH
Stuttgart, Germany
Helios Klinikum Wuppertal GmbH
Wuppertal, Germany
Institut de Recerca - Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital รlvaro Cunqueiro de Vigo
Vigo, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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