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

Conditions

• Off Pump Coronary Artery Bypass Surgery

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vacuum Stabilizer System — DEVICE
  Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.
• Vacuum Positioner System — DEVICE
  Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.
• Blower/Mister — DEVICE
  Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.
• Proximal Seal System — DEVICE
  Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.

Study Details

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.

Key Dates

Start date

Mar 4, 2026

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: Getinge Beating heart study devices group

Primary Outcome Measure

Incidence of device-related adverse events [ Time Frame: Time period from procedure through study completion, an average of 7 days ]

Central Contacts

• Sr. Manager, Clinical Affairs
  603-921-7318
  [email protected]

Locations (2)

Find similar trials in Stockton, CA