Non-invasive Pulmonary Artery Prediction

Study Overview
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Brief Summary
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Cardiac remote monitoring devices have expanded our ability to track physiological changes used in the diagnosis and management of patients with cardiac disease. Implantable remote monitoring technologies have been shown to predict heart failure events, and guide therapy to reduce heart failure hospitalizations. The CardioMEMs System, the most studied and established remote monitoring system, relies on a pulmonary artery implant for continuous PAP measurement. However, there are no commercially available wearable systems that can reproduce continuous PAP tracings. This study aims to determine if a machine-learning algorithm with data from a wearable cardiac remote-monitoring system incorporating EKG, heart sounds, and thoracic impedance can reproduce a continuous PAP tracing obtained during right heart catheterization.

Official Title
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Study to Determine if Novel Wearable Monitoring System and Machine-Learning Algorithm Can Model Continuous Pulmonary Artery Pressure Recordings in Human Subjects

Conditions
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Heart Failure, Pulmonary Arterial Hypertension

Intervention / Treatment
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* Device: catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18+ years Undergoing a right heart cardiac catheterization or in the cardiac care unit with active monitoring using an arterial line or Swan-Ganz catheter. Exclusion Criteria: Vulnerable population Unable to consent for any reason Unstable patient Known skin reaction to latex or adhesives

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Catheterization Arm<br>Participants will be limited to adults older than 18 years of age, able to consent, planned for the cardiac catheterization lab for a right heart catheterization or in the cardiac care unit with an existing arterial line or Swan-Ganz catheter actively measuring the pulmonary artery pressure on a continuous basis. | Device: catheterization<br>* Swan-Ganz catheterization (also called right heart catheterization or pulmonary artery catheterization) is the passing of a thin tube (catheter) into the right side of the heart and the arteries leading to the lungs. It is done to monitor the heart's function and blood flow and pressures in and around the heart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation of pulmonary artery pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm | The primary objective of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous pulmonary artery pressure obtained during right heart catheterization or data obtained from a Sawn Ganz catheter already in place in the setting of cardiac care unit admission. | the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes. | 
| The correlation of pulmonary artery wedge pressure values measured by Sawn Gan catheter and that derived by a machine learning algorithm | The second objective of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous pulmonary artery wedge pressure obtained during right heart catheterization or data obtained from a Sawn Ganz catheter already in place in the setting of cardiac care unit admission. | the Swan-Ganz catheter obtains wedge pressures first for a minimum of 20 seconds (20-30 seconds). |