The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Nanowear Inc.13 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Right Heart Catheterization

Interventions

SimpleSenseDEVICE

The study is observational only. No interventions will be triggered by the SimpleSense device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has provided informed consent 2. Male or female over the age of 18 years 3. The patient is undergoing right heart catheterization Exclusion Criteria: 1. Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System. 2. Subjects who are pregnant 3. Severe aortic stenosis.

Locations (1)

Westchester Medical Center

Valhalla, New York, United States

Outcomes

Primary Outcomes

Cardiac output algorithm

To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.

Time frame: 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

Time frame: 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

Time frame: 9-12 months

Data from ClinicalTrials.gov

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