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Wearable device aims to cut heart failure hospital stays

NCT ID NCT05650541

Disease control Sponsor: Analog Device, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study is testing a wearable system called Sensinel CPM to see if it can help people with chronic heart failure avoid hospital visits and reduce healthcare costs. About 1200 participants with moderate to severe heart failure will use the device, and their results will be compared to those who don't use it. The goal is to improve quality of life and care while lowering expenses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following: * NYHA Class III HF * NYHA Class IV HF OR * NYHA Class II HF with one or more of the following: * Chronic Kidney Disease (eGFR\<60 within the past 6 months) * HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200 pg/ml\* for patients not in AF or \> 600 pg/ml\* for patients in AF on screening ECG+ * NT-proBNP \> 300 pg/ml\* for patients not in AF or \> 900 pg/ml\* for patients in AF on the screening visit ECG+ * Chronic obstructive pulmonary disease (COPD) Exclusion Criteria: * Under 18 years of age * Patients with severe COPD (GOLD stage III or IV) * Limited mobility preventing application of device or no caregiver to assist * Cognitive impairments that would limit the application and proper use of the device * Skin allergies or skin sensitivities to silicone-based adhesives * Pregnancy (method of assessment at the discretion of the PI) * Not willing to shave chest hair if needed to apply device * Patients on chronic IV ionotropic therapy - (Milrinone, Dobutamine, and Dopamine) * Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator * No cellular coverage (Patient's Home)\*\* * Skin breakdown on the left chest or breast area

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baptist Health South Florida

    RECRUITING

    Miami, Florida, 33173, United States

  • Baystate Medical Center

    COMPLETED

    Springfield, Massachusetts, 01199, United States

  • Cone Health

    COMPLETED

    Greensboro, North Carolina, 27401, United States

  • Desert Oasis Healthcare

    COMPLETED

    Palm Springs, California, 92262, United States

  • Orlando Health

    RECRUITING

    Orlando, Florida, 32806, United States

  • Prisma Health

    COMPLETED

    Greenville, South Carolina, 29601, United States

  • University of Nebraska Medical Center

    COMPLETED

    Omaha, Nebraska, 68189, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.