Fetal and Neonatal Magnetophysiology

NCT01903564 | Completed Results

• 2 other identifiers: 2013-0362R01HL063174
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fetus; fetal arrhythmia; fetal heart rate; long QT syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

  15 weeks' gestation to birth

Study Arms (2)

normal

pregnant women with uncomplicated pregnancies

Device: magnetocardiography; Device: fetal echocardiography

high-risk

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

Device: magnetocardiography; Device: postnatal ECG; Device: fetal echocardiography

Interventions

magnetocardiography DEVICE

recording of magnetic heart activity

Also known as: MCG, fetal magnetocardiography

high-risk; normal

postnatal ECG DEVICE

postnatal ECG

Also known as: electrocardiography

high-risk

fetal echocardiography DEVICE

fetal echocardiography

Also known as: Doppler ultrasound, M-mode ultrasound, 2d ultrasound

high-risk; normal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We plan to study a total of 180 subjects. Sixty will be pregnant women with uncomplicated pregnancies; 120 will be pregnant women with pregnancies complicated by fetal arrhythmia or a condition that puts the fetus at risk of fetal arrhythmia. We refer to these cases as "high-risk" due to the presence of or risk of arrhythmia to the fetus. The pregnant mothers will be age 18 or older. They will be studied as early as 15 weeks' gestation and may be asked to return, if their physician determines that additional fMCG studies are necessary.

You may qualify if:

• Normal subjects: normal, healthy adult women with uncomplicated pregnancies

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Shared Medical Technology, Inc.: collaborator
• Medical College of Wisconsin: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Long QT Syndrome

Interventions

Magnetocardiography; Electrocardiography; Ultrasonography, Doppler; Ultrasonography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques; Diagnostic Imaging

Results Point of Contact

• Title: Ronald Wakai, Ph.D.
• Organization: University of Wisconsin-Madison

rtwakai@wisc.edu

6082654988

Study Officials

• Ronald Wakai, Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Janette Strasburger, M.D.

  Medical College of Wisconsin

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 19, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2018
• Last Updated: May 29, 2019
• Results First Posted: February 7, 2018

Record last verified: 2019-05

Locations

US (1)