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

ConditionOff Pump Coronary Artery Bypass Surgery

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age22+

SponsorMaquet Cardiovascular

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Getinge Beating heart study devices group4 interventions

Trial outcomes

Primary outcomes

Incidence of device-related adverse events

Incidence of device-related adverse events for each subject

Time frame

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 frame

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.

Time frame

Perioperative/Periprocedural