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

Recruiting now

Conditions studied: Congenital Heart Disease, Congenital Vascular Disorder, Congenital Cardiomyopathy, Pregnancy Related

In brief

Congenital heart disease (CHD) includes a wide variety of types of disease, including congenital abnormalities of the heart valves. This can range from bicuspid aortic valve and other aortic valve deformities to more complex disease such as tetralogy of Fallot. For many kinds of CHD, the optimal timing of interventions remains unclear. For instance, in tetralogy of Fallot, there is still equipoise about when to offer pulmonary valve replacement (PVR), while in aortic regurgitation, some patients can remain stable for many years. The primary focus of this study is to use continuous physiologic data (CPD), obtained using wearable biosensors (a type of biometric monitoring technology), to develop improved biomarkers of disease progression and prognosis from patients with congenital heart disease (CHD) who are pregnant while they are at home as well as looking at patients' experience and interaction with wearable biosensor technology at home.

Key facts

Study ID

NCT06818760

Run by

The Cleveland Clinic

People needed

50

Starts

2025-01-27

Expected to finish

2028-12-31

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients on hemodialysis

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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