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Heart Failure

Nanowear Heart Failure Management Multi-sensor Algorithm

Sponsored by Nanowear Inc.

About this trial

Last updated 2 years ago

Study ID

NWCT18-SS-001

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 months ago

What is this trial about?

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)

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status

Recruiting