NCT04362553

Brief Summary

Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

April 15, 2020

Last Update Submit

September 27, 2022

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Percent agreement with pilot sensor and current standard of vital signs monitoring

    Percent agreement with pilot sensor and current standard of vital signs monitoring

    2 years

Study Arms (1)

Adults

Adults scheduled to receive a TTE (Trans-esophogeal echocardiogram)

Device: wearable vital signs sensor

Interventions

wearable vital signs sensorDEVICE

vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization

Adults

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiology patients

You may qualify if:

  • Patient's aged 18-65
  • Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring

You may not qualify if:

  • Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
  • Patients undergoing exercise or drug induced cardiac stress test
  • Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 27, 2020

Study Start

June 1, 2020

Primary Completion

November 23, 2020

Study Completion

September 5, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)