The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial
Sponsor: Nanowear Inc.
Trial Details
| Condition | Heart Failure |
| Intervention | SimpleSENSE |
| Status | Terminated |
| Participants | 13 |
| Est. Completion | 22 Mar 2021 |
| Last Updated | 9 Apr 2026 |
Primary Outcome
Multi-parameter algorithm
Eligibility Criteria
Inclusion 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 Sites
Countries
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