MedTrace Logo

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

NCT06818760 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease
  • Congenital Vascular Disorder
  • Congenital Cardiomyopathy
  • Pregnancy Related

Interventions

DIAGNOSTIC_TEST

Masimo Smart Wristband

Continuous wear of Masimo Smart Wristband

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Joanna Ghobrial, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06818760 on ClinicalTrials.gov