Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
NCT ID: NCT07286890
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2026-01-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Getinge Beating heart study devices group
Vacuum Stabilizer System
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
Vacuum Positioner System
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
Blower/Mister
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
Proximal Seal System
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
Interventions
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Vacuum Stabilizer System
Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
Vacuum Positioner System
Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
Blower/Mister
Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
Proximal Seal System
Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.
Eligibility Criteria
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Inclusion Criteria
* 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 who undergo either planned or unplanned conversion to on pump with arrested heart where Getinge's Beating Heart product(s) have not been used.
22 Years
ALL
No
Sponsors
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Maquet Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Bulger
Role: STUDY_DIRECTOR
Getinge
Central Contacts
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Other Identifiers
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MCV00110458
Identifier Type: -
Identifier Source: org_study_id