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Smart vest could spot heart rhythm problems without needles or radiation

NCT ID NCT07425132

Diagnosis Sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a new non-invasive vest that uses 128 electrodes to map the heart's electrical activity in people with congenital heart disease. The goal is to see if this method can accurately identify areas causing abnormal heart rhythms without needing invasive procedures or radiation from CT scans. Fifteen adults with congenital heart disease who are already scheduled for an invasive heart study will wear the vest to compare results.

What this could mean

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

What this could lead to
If successful, this could provide a safer, non-invasive way to locate heart rhythm problems in people with congenital heart disease, reducing the need for radiation and invasive procedures.
What could go wrong
This is a very small early study with only 15 participants, so results may not apply to everyone. The technology may not be accurate enough for complex heart defects.

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

About 15 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 (≥18 years) diagnosed with congenital heart disease (simple, moderate, or complex congenital heart defects ranging from atrial septal defects to complex single-ventricle anatomies such as Fontan circulation) who are referred to the Electrophysiology Unit or Cardiology Department for clinical management of arrhythmias. Eligible patients will be invited to participate during their pre-procedural consultation or upon admission for their scheduled intervention. Specifically, participants will be selected from the following clinical streams: (1) Catheter ablation candidates presenting with symptomatic tachyarrhythmias (atrial or ventricular) that have a clinical indication for an invasive electroanatomical mapping and ablation procedure (2) Device implantation candidates referred for the implantation or upgrade of intracavitary stimulation devices, including permanent pacemakers, ICDs or CRT. The recruitment process aims to capture a representative spectrum of CHD complexity,

Ages

18 to 80 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: * Patients with congenital pathologies and a clinical indication for an invasive electroanatomical study and/or implantation of intracavitary stimulation devices. * Written informed consent form signed to participate in the study. * Ability to stand upright to allow for the 3D torso reconstruction required by the ECGI system. Exclusion Criteria: * Patients under 18 years of age. * Inability to undergo endocardial catheterization (e.g., pregnant or breastfeeding women). * Physical or mental incapacity to understand and accept the informed consent.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac congenital heart disease

As listed by the trial registrant

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

Congenital heart disease

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

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, Madrid, 28007, Spain

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