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NCT05629533
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
Conditions: Right Heart Catheterization
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
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.
Eligibility Criteria
Inclusion Criteria:Subject has provided informed consentMale or female over the age of 18 yearsThe patient is undergoing right heart catheterizationExclusion Criteria:Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.Subjects who are pregnantSevere aortic stenosis.
Source: ClinicalTrials.gov (NCT05629533). StuddyBuddy aggregates publicly available trial information.