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RECRUITING
NCT06818760

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

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.

Official title: Single Center Pilot Study of Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-01-27

Completion Date

2028-12-31

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Masimo Smart Wristband

Continuous wear of Masimo Smart Wristband

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States