Back to Trials
NCT07286890Recruiting

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

Maquet Cardiovascular

Start Date

3/4/2026

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 22 years to No maximum

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.

Interventions

DEVICE

Vacuum Stabilizer System

DEVICE

Vacuum Positioner System

DEVICE

Blower/Mister

DEVICE

Proximal Seal System

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Off Pump Coronary Artery Bypass Surgery

Locations

St. Joseph's Medical Center Stockton

Stockton, California 95204

United States

Aspirus Medical Group

Wausau, Wisconsin 54401

United States

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Stuttgart, 70376

Germany

Helios Klinikum Wuppertal GmbH

Wuppertal, 42283

Germany

Institut de Recerca - Hospital Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Álvaro Cunqueiro de Vigo

Vigo, 36212

Spain