Actively Recruiting
Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
Led by The Cleveland Clinic · Updated on 2026-02-13
50
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 group 6 II or higher.
- Includes specific mWHO classes: II, II-III, III, and IV with detailed heart conditions as described.
- Congenital valvular heart disease with moderate or greater regurgitation or stenosis by echocardiography.
- Bioprosthetic valvular heart disease with moderate or greater regurgitation or stenosis.
- Any mechanical valve prosthesis.
- Congenital cardiomyopathy with ejection fraction less than 50%.
- Provide informed consent.
- Age 18 years or older.
You will not qualify if you...
- Patients on hemodialysis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
Joanna Ghobrial, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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