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Smartwatch study aims to keep pregnant heart patients safer at home

NCT ID NCT06818760

Knowledge-focused Sponsor: The Cleveland Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a wrist-worn device can help monitor pregnant women with congenital heart disease. Researchers will track heart rhythms and other data from 50 participants to see if the wearable can detect early signs of trouble. The goal is to improve care and reduce the need for frequent clinic visits.

What this could mean

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

Active substance
Masimo Smart Wristband
What this could lead to
If successful, this could lead to better home monitoring tools for pregnant women with heart conditions, potentially catching problems earlier.
What could go wrong
This is a small, early pilot study with only 50 participants, so results may not apply to everyone. The wearable may not detect all complications accurately.

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 50 people

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

Started

Jan 2025

Expected to finish

Dec 2028

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

Women greater or equal to 18 years of age who have a congenital heart disease (congenital valvular heart disease, Native valvular heart disease, bioprosthetic valvular heart disease, any mechanical valve prosthesis and congenital cardiomyopathy with EF less then 50%) who are pregnant from high risk obstetric clinic.

Ages

18 years and older

Sex

Female participants only

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: Women evaluated in the cardio-obstetrics clinic either prepartum, intrapartum, or postpartum with congenital heart disease. * Congenital heart disease: Based on modified World Health Organization (mWHO) classification of maternal cardiovascular disease group ≥ II. * mWHO Class I include mild pulmonary stenosis, uncomplicated patent ductus arteriosus, and repaired shunts, to be excluded. * mWHO Class II includes unoperated atrial septal defect or ventricular septal defect and repaired tetralogy of Fallot. * mWHO Class II-III includes mild left ventricular impairment, valvular heart disease not in class I, repaired aortic coarctation, Marfan without aortic dilation, bicuspid aortic valve with \<45 mm root, hypertrophic cardiomyopathy. * mWHO Class III includes systemic right ventricle, Fontan circulation, unrepaired cyanotic heart disease, Marfan with aorta 40-45 mm, bicuspid aortic valve with root 45-50 mm, other complex congenital heart disease (such as Shone complex). * mWHO Class IV includes Marfan with \>45 mm aorta, bicuspid aortic valve with \> 50 mm aorta, severe systemic ventricular dysfunction (EF\<30%), severe symptomatic AS or MS, native severe coarctation, all severe pulmonary hypertension patients from any cause. * Congenital valvular heart disease: * Native valvular heart disease: tricuspid, pulmonary, mitral and aortic with ≥ moderate regurgitation or stenosis by echocardiography. * Bioprosthetic valvular heart disease with ≥ moderate regurgitation or stenosis by echocardiography. * Any mechanical valve prosthesis * Congenital Cardiomyopathy * Cardiomyopathy with EF \< 30% * Cardiomyopathy with EF 30-50% * Provide Informed consent * Age \> 18 years of age Exclusion Criteria: * Patients on hemodialysis

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Conditions

The condition(s) this trial relates to.

congenital heart disease congenital vascular malformation histiocytoid cardiomyopathy pregnancy disorder

As listed by the trial registrant

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

Congenital cardiomyopathy Congenital heart disease Congenital vascular disorder Pregnancy related

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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

More trials for these conditions

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