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

Maquet

Status

Not yet enrolling

Conditions

Off Pump Coronary Artery Bypass Surgery

Treatments

Device: Vacuum Positioner System

Device: Vacuum Stabilizer System

Device: Proximal Seal System

Device: Blower/Mister

Study type

Observational

Funder types

Industry

Identifiers

NCT07286890

MCV00110458

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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.