The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

April 6, 2026 updated by: Nanowear Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase 1

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
The study is observational only. No interventions will be triggered by the SimpleSense device
Phase 2
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
The study is observational only. No interventions will be triggered by the SimpleSense device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output algorithm
Time Frame: 9-12 months
To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.
9-12 months
Algorithm for Pulmonary Artery Pressure
Time Frame: 9 -12 months
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
Time Frame: 9-12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanowear Inc.

Collaborators

Westchester Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2023

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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