MedTrace Logo

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

NCT07286890 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Off Pump Coronary Artery Bypass Surgery

Interventions

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.

Sponsors & Collaborators

  • Maquet Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Elizabeth Bulger · Getinge

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286890 on ClinicalTrials.gov