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

NCT07286890 | Recruiting FDA Device

• 1 other identifier: MCV00110458
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Incidence of device-related adverse events

  Incidence of device-related adverse events for each subject

  Time period from procedure through study completion, an average of 7 days

• Incidence of device-related serious adverse events

  Incidence of device-related serious adverse events experienced by subjects

  Time period from procedure through study completion, an average of 7 days

• Incidence of technical success

  Incidence of technical success, based on the number of patients who have documented successful use and performance of the study device(s) when used as intended, out of the study population.

  Perioperative/Periprocedural

Study Arms (1)

Getinge Beating heart study devices group

Device: Vacuum Stabilizer System; Device: Vacuum Positioner System; Device: Blower/Mister; Device: Proximal Seal System

Interventions

Vacuum Stabilizer System DEVICE

Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.

Getinge Beating heart study devices group

Vacuum Positioner System DEVICE

Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.

Getinge Beating heart study devices group

Proximal Seal System DEVICE

Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.

Getinge Beating heart study devices group

Blower/Mister DEVICE

Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.

Getinge Beating heart study devices group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing beating heart coronary artery bypass surgery where 1 or more Beating Heart study products are used according to the device labeling.

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maquet Cardiovascular: lead

Study Sites (2)

St. Joseph's Medical Center Stockton

Stockton, California, 95204, United States

RECRUITING

Aspirus Medical Group

Wausau, Wisconsin, 54401, United States

RECRUITING

Study Officials

• Elizabeth Bulger

  Getinge

  STUDY DIRECTOR

Central Study Contacts

Sr. Manager, Clinical Affairs

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: March 4, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)