NCT07286890

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Maquet Cardiovascular · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-16
• Last updated: 2026-03-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study