Nanowear Heart Failure Management Multi-sensor Algorithm

Stopped early

Conditions studied: Heart Failure

In brief

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)

Key facts

Study ID

NCT03719079

Run by

Nanowear Inc.

People needed

13

Starts

2019-08-21

Expected to finish

2024-06-18

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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