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Smart watch for the heart: can remote monitoring save lives?

NCT ID NCT07247032

Disease control Sponsor: Implicity 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new remote monitoring system called SmartSignalHF in 1132 adults with heart failure who have an implanted heart device (ICD or CRT-D). The goal is to see if this system can reduce deaths and hospital stays over 12 months compared to standard care. Participants must be 18-85 years old with moderate heart failure and a reduced pumping ability.

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 1,132 people

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

Started

Dec 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 85 years

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: * Patient aged 18-85 * Patient diagnosed with a New York Heart Association (NYHA) class II or III * Patients with left ventricular ejection fraction ≼ 40 % * Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic) * Non-activation of others HF multisensor algorithms * Patient remote monitored on Implicity CIED platform * Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring * Patient is willing to be remotely monitored for heart failure * HF treated according to European Society of Cardiology (ESC) guidelines Exclusion Criteria: * Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures * Patients with a life expectancy of less than 12 months * Patients enrolled in concurrent clinical studies * Patients with a history of non-compliance with medical care or inability to comply with the study protocol * Patients already receiving remote monitoring for heart failure * Pregnant or breastfeeding women * Subjects under legal protection

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Conditions

The condition(s) this trial relates to.

heart failure mild heart failure moderate heart failure systolic heart failure

As listed by the trial registrant

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

CRT and/or icd Heart failure Heart failure nyha class II Heart failure nyha class III Heart failure with reduced ejection fraction (hfref) Heart failure; with decompensation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Implicity

    RECRUITING

    Paris, 75002, France

    Contact Email: •••••@•••••

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