Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables (NCT06818760)
Single Center Pilot Study of Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cleveland Clinic — Cleveland, Ohio
Age range: 18 Years
🧪 Interventions in This Study
- Masimo Smart Wristband (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (216) 444-5923
Email: GHOBRIJ@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Congenital Heart Disease
- Technical Development for Pediatric Cardiovascular MRI — Washington D.C., District of Columbia
- Harmony TPV Post-Approval Study — Birmingham, Alabama
- The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study — Los Angeles, California
- Autus Valve Pivotal Study — Los Angeles, California
- Peer Coaching Intervention in Young Adults With Congenital Heart Disease — Durham, North Carolina
- SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure — Toronto, Ontario
Explore by condition: All Congenital Heart Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.