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TerminatedNo phase

The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Reason given: Logistics and low enrollment.

Key facts

Where
Valhalla, United StatesSee the site

Where in United States

  • Westchester Medical CenterValhalla, United StatesNo longer taking part

Trial details

Who runs it
Nanowear Inc.
Trial code
NCT05629533
Record updated
9 April 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: Subject has provided informed consent; Male or female over the age of 18 years; The patient is undergoing right heart catheterization.

Exclusion: Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System; Subjects who are pregnant; Severe aortic stenosis.

ClinicalTrials.gov NCT05629533