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.
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.
Patients on hemodialysis
Women greater or equal to 18 years of age who have a congenital heart disease (congenital valvular heart disease, Native valvular heart disease, bioprosthetic valvular heart disease, any mechanical valve prosthesis and congenital cardiomyopathy with EF less then 50%) who are pregnant from high risk obstetric clinic.
Cohort
Prospective
Masimo Smart Wristband
Diagnostic testContinuous wear of Masimo Smart Wristband
New onset atrial or ventricular arrhythmias
New onset of atrial tachycardia, flutter or fibrillation, non-sustained VT (3 or more PVC, lasting \<30 seconds), PVC burden \>10% within 24 hours detected on ECG or event monitors on clinic visits or prompted by subjective palpitations, ECG or event monitor obtained routinely due to clinical suspicion of arrhythmia.
Increased NT-proBNP
Change in value of \>200 pg/mL in the first and second trimester, and \>150 pg/mL in the third trimester
New or worsening of biventricular dysfunction or valvular dysfunction on echocardiography
a reduction in EF by \>5%. New or worsening valvular dysfunction is defined as an increase in valve dysfunction by 1 grade of severity (mild, moderate, severe) on echocardiography.
Cardiac-related hospital or intensive care unit (ICU) admission
Number of occurrence of cardiac-related hospital or ICU admission
Inotropic or mechanical circulatory support
Number of occurrence of inotropic or mechanical circulatory support
Click on the lead sponsor to view all of their trials.
