Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 9/9/2018 |
Start Date: | April 2015 |
End Date: | December 2017 |
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.
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.
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
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