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.
Study Type
OBSERVATIONAL
Enrollment
1,046
This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge
Veterans Affairs Medical Center
Washington DC, Maryland, United States
Mount Sinai Beth Israel
New York, New York, United States
University of Calgary
Calgary, Alberta, Canada
University of Duisburg-Essen, Dept. of Cardiothoracic Surgery
Essen, Germany
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
Time frame: 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
Time frame: Day 1 (During surgery)
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
Time frame: 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
Time frame: 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
Time frame: 2 years (Throughout the study)
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Clinica Cardiochirurgica
Chieti, Italy
Erasmus University Medical Center
Rotterdam, Netherlands
University of Oxford
Oxford, United Kingdom