Fetal and Neonatal Magnetophysiology
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/9/2018 |
| Start Date: | March 2014 |
| End Date: | June 2016 |
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.
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.
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