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NCT06818760 · ClinicalTrials.gov registry record
Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
A clinical trial of Pregnancy Related and Congenital Heart Disease, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT06818760: Recruiting study of Pregnancy Related and Congenital Heart Disease, sponsored by The Cleveland Clinic.
NCT06818760 is a study of Pregnancy Related and Congenital Heart Disease that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06818760, a study of Pregnancy Related and Congenital Heart Disease, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Masimo Smart Wristband
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2028-12-31 |
What NCT06818760 shows while recruiting
NCT06818760 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which Masimo Smart Wristband is the first listed.
NCT06818760 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06818760 about?
NCT06818760 is a clinical study titled "Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables". 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 ti...
What is the current status of trial NCT06818760?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2025-01-27. Estimated completion is 2028-12-31.
What conditions does trial NCT06818760 study?
This clinical trial studies the following conditions: Pregnancy Related, Congenital Heart Disease, Congenital Vascular Disorder, Congenital Cardiomyopathy.
What interventions are being tested in trial NCT06818760?
The interventions under investigation include: Masimo Smart Wristband (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06818760?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06818760 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06818760's enrollment target sits among peer trials
50 76th of 99 higher than 19 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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