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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06818760
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Masimo Smart Wristband — DIAGNOSTIC_TEST
    Continuous wear of Masimo Smart Wristband

Study Details

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.

Key Dates

Start date
Jan 27, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Masimo Smart Wristband
    Masimo Smart Wristband continuous ambulatory monitoring

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Joanna Ghobrial, MD
[email protected]
216-444-5923
Justin Lappen, MD (SUB_INVESTIGATOR)

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Cleveland Clinic· Cleveland, OH

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