Cardiac Function Non-Invasive Monitoring System Evaluation Trial

NCT04131725 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 275

Last updated 2023-11-22

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131725 on ClinicalTrials.gov