Nanowear Heart Failure Management Multi-sensor Algorithm

RECRUITING

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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

🗓️ Study Start (Actual) 21 August 2019

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) December 2024

👥 Enrollment (Estimated) 500

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Hershey, Pennsylvania, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 23 October 2018
First Submitted that Met QC Criteria 23 October 2018
First Posted 25 October 2018

Study Record Updates

Last Update Submitted that Met QC Criteria 7 November 2023
Last Update Posted 8 November 2023
Last Verified November 2023