The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Study Overview
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Brief Summary
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The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.

Detailed Description
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Patients undergoing right heart catheterization for a clinical indication including but not limited to prognosis for advanced heart failure, during endomyocardial biopsy, candidacy for heart transplant or management of cardiogenic shock. Study Design: The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization. Number of subjects and sites: The Nanowear SimpleSense study will enroll up to 100 subjects to collect data at Westchester Medical Center. The testing will include a SimpleSense device recording and simultaneous measurement of Cardiac Output, and Pulmonary Artery Pressure by right heart catheterization. Duration of study: The duration of the Nanowear SimpleSense study is expected to be 1 year. Study Population: Subjects of legal age to give informed consent who are undergoing right heart catheterization for a clinical indication including but not limited to : Prognosis of advanced heart failure During endomyocardial biopsy Candidacy for heart transplant Management of cardiogenic shock

Official Title
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The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization

Conditions
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Right Heart Catheterization

Intervention / Treatment
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* Device: SimpleSense


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent Male or female over the age of 18 years The patient is undergoing right heart catheterization Exclusion Criteria: Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System. Subjects who are pregnant Severe aortic stenosis.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Phase 1<br>Subjects to undergo right heart catheterization SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values. Undergoing right heart catheterization for a clinical indication including but not limited to : Prognosis of advanced heart failure During endomyocardial biopsy Candidacy for heart transplant Management of cardiogenic shock | Device: SimpleSense<br>* The study is observational only. No interventions will be triggered by the SimpleSense device<br>|
| Phase 2<br>Subjects to undergo right heart catheterization SimpleSense data collected from the second set of subjects and evaluate the algorithms developed to estimate cardiac output from SimpleSense data. The second set of subjects are from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization. | Device: SimpleSense<br>* The study is observational only. No interventions will be triggered by the SimpleSense device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output algorithm | To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization. | 9-12 months | 
| Algorithm for Pulmonary Artery Pressure | To train a model for Pulmonary Artery Pressure estimation based on the data acquired for SimpleSense against the Pulmonary Artery Pressure data from the right heart catheterization | 9 -12 months | 
| Algorithm for Pulmonary Wedge Pressure | To train a model for Pulmonary Wedge Pressure estimation based on the data acquired for SimpleSense against the Pulmonary Wedge Pressure data from the right heart catheterization | 9-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac output, Right heart catheterization, SimpleSense, Algorithm, Pulmonary Artery Pressure, Heart failure, Endomyocardial biopsy, Cardiogenic shock