Cardiac Performance System Data Collection Study

NCT ID: NCT05866666

Last Updated: 2023-11-21

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

RECRUITING

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-30

Study Completion Date

2024-05-31

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 scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.

Cardiac Performance System (NSR)

Intervention Type DEVICE

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.

Interventions

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Cardiac Performance System (NSR)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent
* 22 years of age or older
* Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria

* Previous Heart Transplant
* Presence of Left Ventricular Assist Device
* Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
* Surgical scars/wounds/bandages/ports at the site of sensor placement
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orlando Health, Inc.

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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Yahaira Ortiz-Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Orlando Health

Locations

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Orlando Health

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sensydia

Role: CONTACT

6618774670

Facility Contacts

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Yahaira Ortiz-Gonzalez, MD

Role: primary

321-843-9657

Other Identifiers

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CPS_ORLANDO

Identifier Type: -

Identifier Source: org_study_id