Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT06818760

Conditions

Congenital Heart Disease

Congenital Vascular Disorder

Congenital Cardiomyopathy

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Masimo Smart Wristband

Study Details

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 Heart Disease

Congenital Vascular Disorder

Congenital Cardiomyopathy

Pregnancy Related

Study ID

NCT06818760

Start date

Jan 27, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Masimo Smart Wristband

Masimo Smart Wristband continuous ambulatory monitoring

Interventions

Masimo Smart Wristband

Continuous wear of Masimo Smart Wristband

Primary outcome measure

  • New onset atrial or ventricular arrhythmias [ Time Frame: Up to 12 month post-partum ]

Central Contacts and Locations

Central contacts

Joanna Ghobrial, MD

216-444-5923GHOBRIJ@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Joanna Ghobrial, MD

216-444-5923GHOBRIJ@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-02-13.