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Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor

NCT04635371 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2021-07-07

No results posted yet for this study

Summary

A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.

Conditions

  • Acute Cardiac Event
  • Acute Cardiac Failure
  • Acute Cardiac Pulmonary Edema

Interventions

DEVICE

Non-invasive Monitoring

Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.

Sponsors & Collaborators

  • Biobeat Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Ronen Rubinshtein, MD · The Edith Wolfson Medical Center

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2021-06-15
Completion
2021-06-30
FDA Device
Yes

Countries

  • Israel

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 NCT04635371 on ClinicalTrials.gov