Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery

Study Overview
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Brief Summary
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The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.

Official Title
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Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery

Conditions
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Coronary Artery Bypass

Intervention / Treatment
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* Device: Medistim device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been scheduled for coronary bypass surgery Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure Subject has been diagnosed with 2-3 vessel disease Exclusion Criteria: Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.) Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing Subject is undergoing an emergency cardiac bypass surgery Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation > 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction) Subject has any condition that the investigator believes should exclude him/her from this registry
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medistim device|This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in planned surgical procedure | Identify how often epiaortic scanning With the Medistim Device, leads to a change in the planned surgical procedure and to identify the reason and the procedure change | Day 1 (During Surgery) | 
| Procedure adaptions | Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function | Day 1 (During surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record number of revisions | Record how many Cardiac bypass patients experience intraoperative graft revision, the type of revision, and the key identifier motivating the revision | Day 1 (During surgery) | 
| Record number of events | Record post-surgical major adverse cardiac and cerebral events (MACCE) of all bypass procedure patients entered into the registry and occuring prior to discharge | Day 1-14 (During hospitalization) | 
| Incidence rate | To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry | 2 years (Throughout the study) |