Fetal and Neonatal Magnetophysiology

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Wisconsin, Madison
Sponsor:
Collaborators:
Shared Medical Technology, Inc.
Medical College of Wisconsin
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01903564
First received: July 11, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Fetal Arrhythmia
Fetal Heart Rate
Long QT Syndrome
Device: magnetocardiography
Device: postnatal ECG
Device: fetal echocardiography

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Fetal and Neonatal Magnetophysiology

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Percentage of subjects experiencing symptoms [ Time Frame: 15-40 weeks' gestation ] [ Designated as safety issue: Yes ]
    Percentage of subjects experiencing symptoms

  • Percentage of subjects experiencing adverse events [ Time Frame: 15 weeks' gestation till up to 1 month after birth ] [ Designated as safety issue: Yes ]
    Percentage of subjects experiencing adverse events

  • Sensitivity and specificity relative to postnatal ECG [ Time Frame: Birth to age 1 week ] [ Designated as safety issue: No ]
    Sensitivity and specificity relative to postnatal ECG for the following diagnoses:(i) fMCG, (ii) the referral echocardiogram, and (iii) the echocardiogram at the time of fMCG study


Secondary Outcome Measures:
  • Percentage of subjects with a change in diagnosis [ Time Frame: 15 weeks' gestation to birth ] [ Designated as safety issue: No ]
    percentage of cases in each of the following categories: i) diagnosis unchanged, fMCG does not support echo diagnosis, ii) diagnosis unchanged, fMCG supports echo diagnosis, iii) change in diagnosis, fMCG resolves ambiguity/provides more specific differential diagnosis, iv) change in diagnosis, fMCG provides significant new information, e.g. undetected rhythm/conduction abnormality.

  • Percentage of subjects with a change in management [ Time Frame: 15 weeks' gestation to birth ] [ Designated as safety issue: No ]
    Percent of cases in each of the following categories: (1) fMCG and referral diagnosis are the same, no change in clinical management, (2) fMCG and referral diagnosis are different, no change in clinical management, (3) fMCG and referral diagnosis are the same, change in clinical management, (4) fMCG and referral diagnosis are different, change in clinical management. To assess the appropriateness of changes due to fMCG, we will also calculate the proportion of observations in each of the following categories: (1) inappropriate change in management due to fMCG, (2) no change in management, and (3) appropriate change in management due to fMCG.


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
normal
pregnant women with uncomplicated pregnancies
Device: magnetocardiography
recording of magnetic heart activity
Other Names:
  • MCG
  • fetal magnetocardiography
Device: fetal echocardiography
fetal echocardiography
Other Names:
  • Doppler ultrasound
  • M-mode ultrasound
  • 2d ultrasound
high-risk
pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia
Device: magnetocardiography
recording of magnetic heart activity
Other Names:
  • MCG
  • fetal magnetocardiography
Device: postnatal ECG
postnatal ECG
Other Name: electrocardiography
Device: fetal echocardiography
fetal echocardiography
Other Names:
  • Doppler ultrasound
  • M-mode ultrasound
  • 2d ultrasound

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We plan to study a total of 125 subjects. Twenty-five will be pregnant women with uncomplicated pregnancies; 100 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 about once every 4 weeks, if their physician determines that additional fMCG studies are necessary.

Criteria

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. They may be excluded if they have a pacemaker or other device that produces large magnetic interference. Pacemakers in a sensing mode typically do not produce large magnetic interference. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903564

Contacts
Contact: Ron Wakai, Ph.D. 6082654988 rtwakai@wisc.edu
Contact: Janette Strasburger, M.D. 4149072333 JStrasburger@chw.org

Locations
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Ronald Wakai, Ph.D.    608-265-4988    rtwakai@wisc.edu   
Contact: William Lutter, Ph.D.    6082659236    wjlutter@wisc.edu   
Sub-Investigator: Shardha Srinivasan, M.D.         
Sponsors and Collaborators
University of Wisconsin, Madison
Shared Medical Technology, Inc.
Medical College of Wisconsin
Investigators
Principal Investigator: Ronald Wakai, Ph.D. University of Wisconsin, Madison
Study Director: Janette Strasburger, M.D. Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01903564     History of Changes
Other Study ID Numbers: 2013-0362, R01HL063174
Study First Received: July 11, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
fetus
fetal arrhythmia
fetal heart rate
long QT syndrome

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Long QT Syndrome
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014