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

NCT06818760 | Recruiting

• 1 other identifier: 24-1183
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 Cardiomyopathy; Pregnancy Related; Congenital Heart Disease; Congenital Vascular Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 month post-partum

Secondary Outcomes (5)

• Increased NT-proBNP

  During the first (up to 12 weeks of gestation) and third trimester (28-40 weeks of gestation)

• New or worsening of biventricular dysfunction or valvular dysfunction on echocardiography

  Up to 12 months post-partum

• Cardiac-related hospital or intensive care unit (ICU) admission

  Up to 12 months post-partum

• Inotropic or mechanical circulatory support

  Up to 12 months post-partum

• Cardiac death

  Up to 12 months post-partum

Study Arms (1)

Masimo Smart Wristband

Masimo Smart Wristband continuous ambulatory monitoring

Diagnostic Test: Masimo Smart Wristband

Interventions

Masimo Smart Wristband DIAGNOSTIC_TEST

Continuous wear of Masimo Smart Wristband

Masimo Smart Wristband

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Patients on hemodialysis

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Cardiomyopathy, infantile histiocytoid

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joanna Ghobrial, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Ghobrial, MD

CONTACT

216-444-5923; GHOBRIJ@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)