Fetal and Neonatal Magnetophysiology
Fetal and Neonatal Magnetophysiology
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.
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.