Fetal and Neonatal Magnetophysiology

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-06-30

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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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normal

pregnant women with uncomplicated pregnancies

magnetocardiography

Intervention Type DEVICE

recording of magnetic heart activity

fetal echocardiography

Intervention Type DEVICE

fetal echocardiography

high-risk

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography

Intervention Type DEVICE

recording of magnetic heart activity

postnatal ECG

Intervention Type DEVICE

postnatal ECG

fetal echocardiography

Intervention Type DEVICE

fetal echocardiography

Interventions

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magnetocardiography

recording of magnetic heart activity

Intervention Type DEVICE

postnatal ECG

Intervention Type DEVICE

fetal echocardiography

Intervention Type DEVICE

Other Intervention Names

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MCG fetal magnetocardiography electrocardiography Doppler ultrasound M-mode ultrasound 2d ultrasound

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes