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Cardiac Performance System Data Collection Study

Cardiac Performance System Data Collection Study

Recruiting
22 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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)

Description

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

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

Study details
    Cardiac Disease

NCT05866666

Sensydia Corporation

26 January 2024

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