Fetal and Neonatal Magnetophysiology

Summary

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.

Conditions

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

Interventions

DEVICE

magnetocardiography

recording of magnetic heart activity

DEVICE

postnatal ECG

postnatal ECG

DEVICE

fetal echocardiography

fetal echocardiography

Sponsors & Collaborators

• Shared Medical Technology, Inc.

  collaborator INDUSTRY

• Medical College of Wisconsin

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Ronald Wakai, Ph.D. · University of Wisconsin, Madison

• Janette Strasburger, M.D. · Medical College of Wisconsin

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2016-06-30

Completion

2018-06-30

Countries

• United States

Study Locations