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

Launched by THE CLEVELAND CLINIC · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how wearable devices, like wristbands, can help monitor the health of pregnant women with congenital heart disease (CHD) from the comfort of their own homes. The goal is to gather continuous health data to better understand how the disease progresses during pregnancy and improve care for these women. This is especially important because women with CHD may face unique challenges during pregnancy, and knowing more about their health can lead to better treatment decisions.

To join this study, participants must be women over 18 years old who have been evaluated in a special clinic for heart-related issues during pregnancy. Eligible conditions include various types of congenital heart disease, valvular heart disease, and specific heart muscle diseases. Participants will wear a device that tracks their health data and will have the chance to share their experiences with this technology. It’s an exciting opportunity to help improve care for other women in similar situations while also receiving close monitoring during their pregnancy.

Gender

FEMALE

Eligibility criteria

• 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, valvular heart disease not in class I, repaired aortic coarctation, Marfan without aortic dilation, bicuspid aortic valve with \<45 mm root, hypertrophic cardiomyopathy.
• • mWHO Class III includes systemic right ventricle, Fontan circulation, unrepaired cyanotic heart disease, Marfan with aorta 40-45 mm, bicuspid aortic valve with root 45-50 mm, other complex congenital heart disease (such as Shone complex).
• • mWHO Class IV includes Marfan with \>45 mm aorta, bicuspid aortic valve with \> 50 mm aorta, severe systemic ventricular dysfunction (EF\<30%), severe symptomatic AS or MS, native severe coarctation, all severe pulmonary hypertension patients from any cause.
• * Congenital valvular heart disease:
• • Native valvular heart disease: tricuspid, pulmonary, mitral and aortic with ≥ moderate regurgitation or stenosis by echocardiography.
• • Bioprosthetic valvular heart disease with ≥ moderate regurgitation or stenosis by echocardiography.
• • Any mechanical valve prosthesis
• • Congenital Cardiomyopathy
• • Cardiomyopathy with EF \< 30%
• • Cardiomyopathy with EF 30-50%
• • Provide Informed consent
• • Age \> 18 years of age
• Exclusion Criteria:
• • Patients on hemodialysis