Heart Failure Clinical Trial
— NanosenseOfficial title:
The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial
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)
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Nanowear Inc. | Hackensack Meridian Health, Milton S. Hershey Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Exploratory comparison of signals from device to NT-proBNP | Exploratory information will be used to compare the signals obtained from the device to the severity of heart failure as measured by clinical evaluation (NYHA functional class and physical examination) and NT-proBNP | 90 days per patient and till 100 Heart Failure events are observed overall. |
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