RecruitingNCT06149143

Cardiac Performance System Data Collection Study - Minnesota


Sponsor

Sensydia Corporation

Enrollment

50 participants

Start Date

Oct 3, 2023

Study Type

OBSERVATIONAL

Conditions

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)


Eligibility

Min Age: 22 Years

Inclusion Criteria3

  • Ability to provide written informed consent
  • 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 Criteria4

  • 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

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Interventions

DEVICECardiac 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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06149143


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