Single Center Pilot Study of Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
The Cleveland Clinic
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.
Description
Maternal cardiovascular disease (MCD) remains the leading cause of death in pregnant women, especially in the United States, where heart disease is on the rise. The worse outcomes disproportionately affect disadvantaged populations, including those with poor access to healthcare, and ethnic minorities. Reducing maternal mortality is a World Health Organization global health goal, and multiple efforts have been initiated to both study maternal cardiac disease as well as reduce morbidity and mortality. At least half of serious cardiac complications can be prevented with closer monitoring and ade…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- Diagnostic TestMasimo Smart Wristband
Continuous wear of Masimo Smart Wristband
Location
- Cleveland ClinicCleveland, Ohio