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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients on hemodialysis

Trial design

Treatments tested in this trial

  • Masimo Smart Wristband

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators