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

September 9, 2026 updated by: Maquet Cardiovascular

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Rostock, Germany
        • Recruiting
        • University Medical Center Rostock
        • Contact:
        • Principal Investigator:
          • Professor Dr. Christian Etz
      • Stuttgart, Germany, 70376
        • Recruiting
        • Robert Bosch Gesellschaft für Medizinische Forschung mbH
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Adrian Ursulescu
      • Wuppertal, Germany, 42283
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Institut de Recerca - Hospital Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Dr. Angela Irabien Ortiz, PhD
        • Sub-Investigator:
          • Dr. Antonino José Ginel Iglesias, PhD
      • Vigo, Spain, 36212
        • Recruiting
        • Hospital Álvaro Cunqueiro de Vigo
        • Contact:
        • Principal Investigator:
          • Dr. Juan Jose Legarra Calderon
  • United States
    • California
      • Stockton, California, United States, 95204
        • Recruiting
        • St. Joseph's Medical Center Stockton
        • Contact:
          • Lucas Anderson
        • Principal Investigator:
          • Mohammad Jamil, MD
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Medical Group
        • Contact:
          • Jamie Slott
        • Principal Investigator:
          • Amanda Eilers, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Getinge Beating heart study devices group
Device: Vacuum Stabilizer System
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
Device: Vacuum Positioner System
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
Device: Blower/Mister
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
Device: Proximal Seal System
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time period from procedure through study completion, an average of 7 days
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
Time period from procedure through study completion, an average of 7 days
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.
Perioperative/Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maquet Cardiovascular

Investigators

  • Study Director: Elizabeth Bulger, Getinge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • MCV00110458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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