Nanowear Heart Failure Management Multi-sensor Algorithm

NCT03719079 | Terminated FDA Device

• 1 other identifier: NWCT18-SS-001
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which includes at least 150 heart failure hospitalizations in participating subjects.The duration of the NanoSense study is expected to be 2 years. The study device is the Wearable Congestive Heart Failure Management System (WCHFS, also known as SimpleSENSE)

Conditions

Heart Failure

Keywords

Fluid decompensation; Non-invasive Multi-parameter monitoring; Multi-parameter algorithm; Heart Rate Variability; Thoracic impedance; Heart Sounds; Respiration; Posture; Activity; Tidal Volume; Stroke Volume

Outcome Measures

Primary Outcomes (1)

• Multi-parameter algorithm

  The primary objective of the study is to develop and validate a multi-parameter algorithm for the detection of heart failure prior to a HF event. For the purpose of this study, a heart failure event will be defined as a hospitalization with a primary diagnosis of heart failure.

  90 days per patient and till 100 Heart Failure events are observed overall.

Secondary Outcomes (1)

• Exploratory comparison of signals from device to NT-proBNP

  90 days per patient and till 100 Heart Failure events are observed overall.

Study Arms (1)

Heart Failure Patients

Patients with primary diagnosis as heart failure

Device: SimpleSENSE

Interventions

SimpleSENSE DEVICE

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

Heart Failure Patients

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 currently or recently hospitalized with a primary diagnosis of heart failure

You may qualify if:

• Subject has provided informed consent
• Male or female over the age of 18 years
• The patient is either hospitalized with a primary diagnosis of acute or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment
• NYHA functional class II-IV at time of enrollment

You may not qualify if:

• Subject unwilling or unable to comply with wearing the Nanowear Congestive Heart Failure Management System 12 hours daily for up to 90 days.
• Subjects who are limited by angina.
• Severe aortic stenosis.
• Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
• Symptomatic ventricular arrhythmias within the past 6 months.
• Subjects who are pregnant will be excluded from this study.

Sponsors & Collaborators

• Nanowear Inc.: lead
• Milton S. Hershey Medical Center: collaborator
• Hackensack Meridian Health: collaborator

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Heart Failure; Respiratory Aspiration; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• John P Boehmer, M.D.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: August 21, 2019
• Primary Completion: March 22, 2021
• Study Completion: June 18, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)