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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1046 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Coronary Artery Bypass

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Medistim device

This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No