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Smartwatches vs. heart disease: brazilian study tests AI-Powered early warning system

NCT ID NCT07174206

Knowledge-focused Sponsor: University of Sao Paulo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a smartwatch, combined with artificial intelligence and remote doctor check-ins, can help detect heart issues like atrial fibrillation and unstable angina earlier than usual. Researchers at the University of Sao Paulo will enroll 520 adults with heart conditions or recent heart procedures. Participants will wear a smartwatch and a portable heart monitor for up to 45 days, and doctors will be alerted if the watch detects something concerning. The goal is to see if this approach is practical, accurate, and could improve patient care.

What this could mean

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

Active substance
Smartwatch and portable holter devices for heart monitoring
What this could lead to
If successful, this could show that smartwatches and AI can help doctors catch heart rhythm problems early and manage patients remotely, potentially reducing hospital visits.
What could go wrong
This is an early feasibility study, not a large treatment trial. The smartwatch may miss some heart events or cause false alarms, and results may not apply to all heart patients.

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 520 people

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

Started

Feb 2025

Expected to finish

Feb 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

22 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: * Patients diagnosed with cardiovascular disease, of both sexes, aged over 22 years; * Provision of informed consent through signature of the Informed Consent Form (ICF); * Assentation to adhere to study procedures and requirements; * Patients indicated for outpatient follow-up due to a cardiovascular condition, or with clinical parameters indicating the need for conventional surgical or catheter-based interventions (e.g., catheter ablation for arrhythmias, transcatheter aortic valve implantation, percutaneous coronary intervention, etc.); * Low or no risk of skin injury, based on Braden Scale clinical criteria or clinical team assessment Exclusion Criteria: * Presence of skin conditions, such as vitiligo, lupus, or atopic dermatitis, as well as tattoos on the wrist that may interfere with the smartwatch's optical sensor readings; * Known sensitivity or history of allergic reactions to components of the wearable devices or related items, such as adhesives or electrodes; * Inability to properly use the wearable monitoring devices due to physical, cognitive, or technological limitations; * Presence of a peripherally inserted central catheter (PICC) or arteriovenous fistula; * Presence of implanted cardiac devices, such as pacemakers, defibrillators, or cardiac resynchronization devices, which prevent ECG acquisition via smartwatch; * Diagnosis of conditions associated with narrowing or obstruction of the aorta and subclavian arteries (e.g., Stanford Type A chronic aortic dissection, Takayasu arteritis, Subclavian Steal Syndrome, or Kawasaki disease), which may cause discrepancies in blood pressure between upper limbs and interfere with study assessments.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiovascular disorder heart disorder intermediate coronary syndrome

As listed by the trial registrant

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

Angina, unstable Atrial fibrillation (AF) Heart diseases

How to take part

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

  1. The places running it

    1 site. 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

  • Instituto do Coracao, HCFMUSP

    RECRUITING

    São Paulo, São Paulo, 05403-900, Brazil

More trials for these conditions

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