Recruiting

Observational Study

Sponsor:

Maquet Cardiovascular

Code:

NCT07286890

Conditions

Off Pump Coronary Artery Bypass Surgery

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Vacuum Stabilizer System

Vacuum Positioner System

Blower/Mister

Proximal Seal System

Study Details

Brief 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

Study ID

NCT07286890

Start date

Mar 4, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Getinge Beating heart study devices group

Interventions

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.

Primary outcome measure

  • Incidence of device-related adverse events [ Time Frame: Time period from procedure through study completion, an average of 7 days ]
  • Incidence of device-related serious adverse events [ Time Frame: Time period from procedure through study completion, an average of 7 days ]
  • Incidence of technical success [ Time Frame: Perioperative/Periprocedural ]

Central Contacts and Locations

Central contacts

Sr. Manager, Clinical Affairs

603-921-7318inka.vesela@getinge.com

Locations

St. Joseph's Medical Center Stockton

Recruiting

Stockton, California, United States, 95204

Principal Investigator:

Mohammad Jamil, MD

Aspirus Medical Group

Recruiting

Wausau, Wisconsin, United States, 54401

Principal Investigator:

Amanda Eilers, MD

More Information

Sponsor

Maquet Cardiovascular

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Maquet Cardiovascular on 2026-06-02.