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The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
Sponsor: Nanowear Inc.
Summary
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.
Official title: The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
13
Start Date
2023-03-08
Completion Date
2025-05-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
SimpleSense
The study is observational only. No interventions will be triggered by the SimpleSense device
Locations (1)
Westchester Medical Center
Valhalla, New York, United States