Cardiac Function Non-Invasive Monitoring System Evaluation Trial
NCT04131725 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 275
Last updated 2023-11-22
Summary
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
Conditions
- Cardiac Disease
Interventions
- DEVICE
-
Cardiac Performance System (NSR)
Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.
Sponsors & Collaborators
-
University of Pittsburgh Medical Center
collaborator OTHER -
Sensydia Corporation
lead INDUSTRY
Principal Investigators
-
William Kaiser, PhD · Sensydia Corporation
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-11-09
- Primary Completion
- 2023-02-01
- Completion
- 2023-04-30
Countries
- United States
Study Locations
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