Nanowear Heart Failure Management Multi-sensor Algorithm

Description

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

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Study Overview

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Study Details

Study overview

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)

The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial

Nanowear Heart Failure Management Multi-sensor Algorithm

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Hershey

Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nanowear Inc.,

John P Boehmer, M.D., PRINCIPAL_INVESTIGATOR, Milton S. Hershey Medical Center

Study Record Dates

2024-12