The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Recruiting

• Conditions: Right Heart Catheterization
• Interventions: Device: SimpleSense

• Registration Number: NCT05629533
• Lead Sponsor: Nanowear Inc.

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.

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 Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-03-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 1	SimpleSense	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
Phase 2	SimpleSense	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.

Primary Outcome Measures

Name	Time	Method
Algorithm for Pulmonary Artery Pressure	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
Cardiac output algorithm	9-12 months	To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.
Algorithm for Pulmonary Wedge Pressure	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

Trial Locations

Locations (1)

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States