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Observational Study of Getinge's Beating Heart Products for Bypass Surgery

This observational study is looking at the safety and performance of Getinge's Beating Heart products during off-pump coronary artery bypass graft (CABG) surgery. These products include the Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister, and Proximal Seal System, which help surgeons perform heart bypass surgery on a beating heart. The study will collect information on how well these devices work and any problems that might occur. You may be eligible if you are at least 22 years old and are scheduled for this type of heart surgery where these devices are expected to be used. The study aims to see how often device-related problems happen and how successful the surgery is using these tools. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
You will not need to undergo any special study procedures. Information will be collected until you are discharged from the hospital after surgery.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected from the time of the procedure through hospital discharge, which is an average of 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07286890

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

Recruiting
Not specifiedAges 22+Observational
Maquet Cardiovascular
~200 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Vacuum Stabilizer SystemVacuum Positioner SystemBlower/MisterProximal Seal System

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of device-related adverse events
Measured over Time period from procedure through study completion, an average of 7 days
+2 more outcomes measured

Conditions

Off Pump Coronary Artery Bypass Surgery

Explore related trials

Coronary Artery Bypass Surgery

Where it's being run

6 sites across 4 states
Germany2
Spain2
California1
Wisconsin1

Study leadership

  • Elizabeth Bulger · STUDY_DIRECTOR · Getinge

Who to contact

Sr. Manager, Clinical Affairs
[email protected]
603-921-7318
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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

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.

What this trial measures

  • Incidence of device-related adverse eventsTime 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 eventsTime period from procedure through study completion, an average of 7 days

    Incidence of device-related serious adverse events experienced by subjects

  • Incidence of technical successPerioperative/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.