Fetal and Neonatal Magnetophysiology

Study Overview
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Brief Summary
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Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow us to investigate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm, with a goal of demonstrating probable benefit from use of the device in patients with serious fetal arrhythmia. We propose a study that will last 1-2 years and will provide data to aid in assessing the safety and effectiveness of fMCG for diagnosis and management of patients with abnormal fetal heart rate and rhythm. We hope that the data from the study will support a Humanitarian Device Exemption (HDE) application for the subject device. The safety and efficacy study designs are described below. High-risk subjects will undergo echocardiography as part of their routine clinical management, and our results will be compared to the echocardiography results, as well as with postnatal ECG, when available. (Since many arrhythmias resolve prior to birth, either due to resolution of disease or due to treatment, only a limited number of diseases allow postnatal comparison). For rhythms that persist after birth, the diagnostic utility of fMCG and echocardiography will be assessed by computing the sensitivity (Sn) and specificity (Sp) relative to postnatal ECG for the following prenatal modalities: (i) the fMCG, (ii) the original (referral) echo, (iii) if available, the in-lab echocardiogram at the time of the fMCG study. Secondary endpoints will assess changes in diagnosis and in clinical management due to the additional information provided by fMCG, compared to the information provided by echocardiography alone.

Official Title
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Fetal and Neonatal Magnetophysiology

Conditions
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Fetal Arrhythmia, Abnormality in Fetal Heart Rate or Rhythm, Long QT Syndrome

Intervention / Treatment
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* Device: magnetocardiography
* Device: postnatal ECG
* Device: fetal echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal subjects: normal, healthy adult women with uncomplicated pregnancies High-risk cohort: The primary inclusion criterion is diagnosis of serious fetal arrhythmia, which is defined as sustained low or high heart rate. Low heart rate, or bradycardia, and high heart rate, or tachycardia, are based on normative values for gestation (usually below 110 -120 beats/min, or above 160-180 beats/min). Intermittent bradycardia and tachycardia are also important to detect because these arrhythmias may become incessant over the course of pregnancy and have implications for patient management. Abnormal repolarization, such as long QT syndrome (LQTS), is another important class of arrhythmia. Fetuses with a family history of LQTS or a suspicious rhythm (low heart rate, intermittent AV block, or ventricular tachycardia) will also be studied. Exclusion Criteria: The pregnant women subjects must by aged 18 or older. High-risk subjects cannot participate if their physician in consultation with the lead physician of the study does not grant permission for them to participate in the study due to risk of travel or other reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal<br>pregnant women with uncomplicated pregnancies | Device: magnetocardiography<br>* recording of magnetic heart activity<br>* Other names: fetal magnetocardiography;Device: fetal echocardiography<br>* fetal echocardiography<br>* Other names: 2d ultrasound;|
| high-risk<br>pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia | Device: magnetocardiography<br>* recording of magnetic heart activity<br>* Other names: fetal magnetocardiography;Device: postnatal ECG<br>* postnatal ECG<br>* Other names: electrocardiography;Device: fetal echocardiography<br>* fetal echocardiography<br>* Other names: 2d ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Experiencing Symptoms | Percentage of subjects experiencing symptoms | 15-40 weeks' gestation | 
| Percentage of Subjects Experiencing Adverse Events Unrelated to Device | Percentage of subjects experiencing adverse events unrelated to device | 15 weeks' gestation till up to 1 month after birth | 
| Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome | Number of Participants with Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome based on measurement of rate-corrected QT interval (QTc) | Birth to age 1 week | 
| Percentage of Subjects Experiencing Adverse Events Related to Device | Percentage of Subjects Experiencing Adverse Events Related to Device | 15 weeks' gestation till up to 1 month after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Fetuses With a Family History of Long QT Syndrome Who a Change in Diagnosis Due to fMCG | Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG | 15 weeks' gestation to birth | 
| Percentage of Fetuses With a Family History of Long QT Syndrome Who Had a Change in Management Due to fMCG | Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG | 15 weeks' gestation to birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fetus, fetal arrhythmia, fetal heart rate, long QT syndrome