Fetal and Neonatal Magnetophysiology

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT01903564
• Collaborator: Shared Medical Technology, Inc. (Industry), Medical College of Wisconsin (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 39
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Arrhythmia; Abnormality in Fetal Heart Rate or Rhythm; Long QT Syndrome	Device: magnetocardiography; Device: postnatal ECG; Device: fetal echocardiography

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 39 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fetal and Neonatal Magnetophysiology
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: electrocardiography ; Device: fetal echocardiography; fetal echocardiography; Other Names: Doppler ultrasound M-mode ultrasound 2d ultrasound

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Experiencing Symptoms [15-40 weeks' gestation]

   Percentage of subjects experiencing symptoms

2. Percentage of Subjects Experiencing Adverse Events Unrelated to Device [15 weeks' gestation till up to 1 month after birth]

   Percentage of subjects experiencing adverse events unrelated to device

3. Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome [Birth to age 1 week]

   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)

4. Percentage of Subjects Experiencing Adverse Events Related to Device [15 weeks' gestation till up to 1 month after birth]

   Percentage of Subjects Experiencing Adverse Events Related to Device

Secondary Outcome Measures

1. 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 a change in diagnosis due to fMCG

2. 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]

   Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Madison	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ronald Wakai, Ph.D., University of Wisconsin, Madison
• Study Director: Janette Strasburger, M.D., Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01903564
• Other Study ID Numbers: 2013-0362; R01HL063174
• First Posted: Jul 19, 2013
• Last Update Posted: May 29, 2019
• Last Verified: May 1, 2019

• 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

Study Results

Participant Flow

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Period Title: Overall Study
STARTED	10	29
COMPLETED	10	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Normal	High-risk	Total
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography	Total of all reporting groups
Overall Participants	10	29	39
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	29 100%	39 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	31.8	32.0	31.9
Sex: Female, Male (Count of Participants)
Female	10 100%	29 100%	39 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	29 100%	39 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Experiencing Symptoms
Description	Percentage of subjects experiencing symptoms
Time Frame	15-40 weeks' gestation

Outcome Measure Data

Analysis Population Description

Symptoms include premature labor, vaginal bleeding, uterine cramping, nausea/vomiting, dizziness, dsypnea, syncope, palpitations, or fatigue during the study session.

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Measure Participants	10	29
Count of Participants [Participants]	0 0%	0 0%

2. Primary Outcome

Title	Percentage of Subjects Experiencing Adverse Events Unrelated to Device
Description	Percentage of subjects experiencing adverse events unrelated to device
Time Frame	15 weeks' gestation till up to 1 month after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Measure Participants	10	29
Count of Participants [Participants]	0 0%	10 34.5%

3. Primary Outcome

Title	Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome
Description	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)
Time Frame	Birth to age 1 week

Outcome Measure Data

Analysis Population Description

Fetuses with a family history of long QT syndrome

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Measure Participants	0	6
Count of Participants [Participants]	0 0%	6 20.7%

4. Primary Outcome

Title	Percentage of Subjects Experiencing Adverse Events Related to Device
Description	Percentage of Subjects Experiencing Adverse Events Related to Device
Time Frame	15 weeks' gestation till up to 1 month after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Measure Participants	10	29
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Percentage of Fetuses With a Family History of Long QT Syndrome Who a Change in Diagnosis Due to fMCG
Description	Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG
Time Frame	15 weeks' gestation to birth

Outcome Measure Data

Analysis Population Description

Fetuses with family history of LQTS

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Measure Participants	0	6
Count of Participants [Participants]	0 0%	3 10.3%

6. Secondary Outcome

Title	Percentage of Fetuses With a Family History of Long QT Syndrome Who Had a Change in Management Due to fMCG
Description	Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG
Time Frame	15 weeks' gestation to birth

Outcome Measure Data

Analysis Population Description

Fetuses with a family history of fetal long QT syndrome

Arm/Group Title	Normal	High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
Measure Participants	0	6
Count of Participants [Participants]	0 0%	2 6.9%

Adverse Events

Arm/Group Title	Normal		High-risk
Arm/Group Description	pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography		pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia magnetocardiography: recording of magnetic heart activity postnatal ECG: postnatal ECG fetal echocardiography: fetal echocardiography
All Cause Mortality
	Normal		High-risk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/29 (0%)
Serious Adverse Events
	Normal		High-risk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		2/29 (6.9%)
Congenital, familial and genetic disorders
fetal death	0/10 (0%)	0	1/29 (3.4%)	1
General disorders
Motor vehicle accident	0/10 (0%)	0	1/29 (3.4%)	1
Other (Not Including Serious) Adverse Events
	Normal		High-risk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.