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Remote Monitoring for Pregnant Women with Congenital Heart Disease

This study is looking at how a wrist wearable device, the Masimo Smart Wristband, can help monitor pregnant women who have congenital heart disease (a heart problem present from birth). The goal is to see if continuous monitoring with this device can help doctors better understand how heart conditions change during and after pregnancy. You might be able to join if you are a woman with congenital heart disease who is being seen in a cardio-obstetrics clinic (a clinic for pregnant women with heart conditions) and your heart condition is classified as mWHO Group II or higher. The study will consider it a success if it can detect new irregular heartbeats (atrial or ventricular arrhythmias) up to 12 months after you give birth. The current status of this study is unclear.

Study design
This is an observational study, meaning participants will be monitored without receiving a specific treatment. It plans to include 50 women.
What's involved
You would continuously wear the Masimo Smart Wristband.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for new irregular heartbeats up to 12 months after giving birth.

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NCT06818760

Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables

Recruiting
Not specifiedAges 18+Observational
The Cleveland Clinic
~50 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Masimo Smart Wristband

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
New onset atrial or ventricular arrhythmias
Measured over Up to 12 month post-partum

Conditions

Congenital Heart Disease
Congenital Vascular Disorder
Congenital Cardiomyopathy
Pregnancy Related

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Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Joanna Ghobrial, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Joanna Ghobrial, MD
[email protected]
216-444-5923
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Patients on hemodialysis

What this trial measures

  • New onset atrial or ventricular arrhythmiasUp to 12 month post-partum

    New onset of atrial tachycardia, flutter or fibrillation, non-sustained VT (3 or more PVC, lasting \<30 seconds), PVC burden \>10% within 24 hours detected on ECG or event monitors on clinic visits or prompted by subjective palpitations, ECG or event monitor obtained routinely due to clinical suspicion of arrhythmia.