Monitoring pregnant women with congenital heart disease using wrist wearables

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on pregnant women with congenital heart disease (CHD) and aims to utilize continuous physiologic data obtained from wearable biosensors to improve biomarkers of disease progression and prognosis. By monitoring these patients at home, the study seeks to enhance understanding of their health status and experiences with wearable technology. The research is particularly relevant given the rising maternal cardiovascular disease rates and the need for better monitoring to prevent serious complications. The study will involve women evaluated in a cardio-obstetrics clinic, ensuring a targeted approach to this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Joanna Ghobrial, MD — The Cleveland Clinic
• Study coordinator: Joanna Ghobrial, MD
• Email: GHOBRIJ@ccf.org
• Phone: 216-444-5923

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.