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Implanted sensors may foresee heart failure crises

NCT ID NCT07753135

Knowledge-focused Sponsor: Samsung Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study looks at whether sensors inside implanted heart devices can warn of worsening heart failure. Researchers will track 500 adults with heart failure or cardiomyopathy who have a Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. By collecting data from routine device checks and remote monitoring, they aim to see if changes in sensor readings are linked to heart failure events like hospitalizations or emergency visits. The goal is to improve remote monitoring and help doctors intervene earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) with HeartLogic, Sleep Incline, and Apnea Scan functions
What this could lead to
If sensor changes reliably predict heart failure worsening, this could enable earlier interventions, fewer hospitalizations, and better remote care for patients with heart failure.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not apply to all patients, and sensor data might not consistently predict worsening heart failure.

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.

Participants

500 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Oct 2027

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.

Who is studied

Adult patients with heart failure or cardiomyopathy implanted with HeartLogic-enabled Boston Scientific ICD or CRT-D devices who are enrolled in the LATITUDE remote monitoring system. Participants are prospectively followed to evaluate the relationship between device-based sensor parameters and clinical heart failure outcomes.

Ages

19 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: * Adults aged 19 years or older who provide written informed consent (or consent from a legally authorized representative when applicable) * Diagnosed with heart failure or cardiomyopathy Implanted with a commercially approved Boston Scientific implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions * Enrolled in the LATITUDE™ (NXT 5.0 or later) remote monitoring system and willing to participate in scheduled remote monitoring and follow-up Exclusion Criteria: * Planned heart transplantation or implantation of a ventricular assist device (VAD), or history of VAD implantation within the previous 12 months * Life expectancy of less than 1 year * Inability or unwillingness to comply with the study protocol or follow-up requirements

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Conditions

The condition(s) this trial relates to.

cardiomyopathy heart failure

As listed by the trial registrant

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

Cardiomyopathy Heart failure

Contacts and locations

Locations

  • Samsung Medical Center

    Seoul, Seoul, 06351, South Korea

More trials for these conditions

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