Cardiac Function Non-Invasive Monitoring System Evaluation Trial

NCT ID: NCT04131725

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-09

Study Completion Date

2023-04-30

Brief Summary

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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)

Detailed Description

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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

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Cardiac Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Function Monitoring

Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods.

Cardiac Performance System (NSR)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults of age 18 or older

Exclusion Criteria

* Subjects with wounds or surgical incisions at the site of sensor placement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Sensydia Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Kaiser, PhD

Role: PRINCIPAL_INVESTIGATOR

Sensydia Corporation

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CPS_002_2019

Identifier Type: -

Identifier Source: org_study_id