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Mini heart monitor implanted in newborns to track dangerous rhythms

NCT ID NCT05744934

Knowledge-focused Sponsor: Boston Children's Hospital 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether a small device called an implantable loop recorder can be safely placed in newborns who have only one working heart chamber. Ten babies received the monitor during their first heart surgery. The goal was to see if the device could continuously track heart rate and catch any abnormal rhythms during the risky period between surgeries. The study focused on safety and whether the device could send data reliably.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

10 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

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

Up to 30 days

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 single ventricle physiology undergoing stage 1 palliation in the 1st month of life Exclusion Criteria: * Prematurity (\<36 weeks gestational age) * Birth weight \<2.5 kg * Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands) * Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices. * Clinical team does not think that the patient is a good candidate

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Conditions

The condition(s) this trial relates to.

univentricular cardiopathy univentricular heart

As listed by the trial registrant

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

Univentricular heart

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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