The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

NCT05629533 | Terminated FDA Device

• 1 other identifier: 14-0044
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Right Heart Catheterization

Keywords

Cardiac output; Right heart catheterization; SimpleSense; Algorithm; Pulmonary Artery Pressure; Heart failure; Endomyocardial biopsy; Cardiogenic shock

Outcome Measures

Primary Outcomes (3)

• Cardiac output algorithm

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

  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

  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

  9-12 months

Study Arms (2)

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

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

Interventions

SimpleSense DEVICE

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

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanowear Inc.: lead
• Westchester Medical Center: collaborator

Study Sites (1)

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 29, 2022
• Study Start: March 8, 2023
• Primary Completion: March 5, 2025
• Study Completion: May 31, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)