Nanowear Heart Failure Management Multi-sensor Algorithm

Launched by NANOWEAR INC. · Oct 23, 2018

Keywords

ClinConnect Summary

The NanoSense study is looking at a new way to manage heart failure using a special device called the Wearable Congestive Heart Failure Management System (WCHFS), also known as SimpleSENSE. This study aims to gather information from up to 500 participants over two years to see how well this device works in monitoring heart failure. The goal is to collect data on at least 150 hospital visits related to heart failure, which will help researchers understand how the device can improve patient care.

To participate in this study, you need to be at least 18 years old and have either just been hospitalized for acute heart failure or discharged from the hospital within the last two weeks. You should also be in classes II to IV of heart failure, meaning your symptoms range from mild to severe. If you agree to join, you’ll need to wear the device for at least 12 hours a day for up to 90 days. It's important to note that some people may not be able to participate, including those with certain heart conditions or who are pregnant. This study is currently recruiting participants of all genders, and your involvement could help improve heart failure management for everyone.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.

Trial Officials