Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
450 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-02-07
Study Completion Date
2028-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fetal and Neonatal Magnetophysiology
NCT01903564
Fetal Arrhythmia
Abnormality in Fetal Heart Rate or Rhythm
Long QT Syndrome
COMPLETED
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
NCT03775954
High Risk Pregnancy
Congenital Heart Disease
Fetal Hydrops
+15 more
RECRUITING
MCG for Localization of Tachyarrhythmia's Origin
NCT06327425
Tachyarrhythmia
Atrial Flutter
Paroxysmal Supraventricular Tachycardia
+3 more
RECRUITING
NA
Fetal Electrocardiogram Extraction-Pilot Study
NCT01681498
Pregnancy
TERMINATED
Can Conventional ECG Technology Capture Fetal Cardiac Activity?
NCT03111173
Fetal Monitoring
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 purpose of the proposed study is to utilize fMCG, the magnetic analog of fetal ECG, to characterize the heart rate and rhythm patterns of fetuses with fetal arrhythmia or at risk of fetal arrhythmia. The study is not intended to be a pivotal study. The subject device is already cleared for clinical use for recording of fetal rhythm; however, FDA has determined that an IDE is required for the proposed study. The study is expected to last approximately 6 years
The Tristan 624 is housed within the magnetically shielded room in the Biomagnetism Laboratory located within the Wisconsin Institutes for Medical Research on the University of Wisconsin-Madison campus.
Protocol
Facilities
The UW Biomagnetism Lab is located within the Wisconsin Institutes for Medical Research, a state-of-the-art translational research facility adjacent to UW Hospitals and Clinics. The study sponsor, Ronald Wakai, PhD, Professor of Medical Physics, is the Laboratory Director. Within the laboratory, medical supervision is provided by Janette Strasburger, MD. The facility is directly adjacent to UW Hospital. An emergency response plan is in place for the facility and for the Biomagnetism Lab. In the study of over 700 pregnancies thus far, the emergency response plan has not been needed.
Subject cohort
The investigators plan to study a total of 300 subjects: 75 will be pregnant women with uncomplicated pregnancies and 225 will be pregnant women with pregnancies complicated by fetal arrhythmia or a condition that puts the fetus at risk of fetal arrhythmia. These cases are considered "high-risk" due to the presence of or risk of serious arrhythmia to the fetus. It will take approximately 5 years from the start of data collection to recruit the subjects and collect and analyze the data. 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.
Inclusion criteria for normal subjects. The pregnant women subjects must be at least 12 weeks pregnant and at least 18 years old. They must have uncomplicated pregnancies.
Exclusion criteria for normal subjects. The pregnant women subjects will be excluded if they are earlier than 12 weeks pregnant or younger than age 18. The 510(k) summary lists no exclusions for the use of the subject device.
Inclusion criteria for high-risk subjects. The pregnant women subjects must be at least 15 weeks pregnant and at least 18 years old. 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 or tachycardia and frequent and/or complex ectopy (irregular rhythm) 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 for high-risk subjects. The pregnant women subjects will be excluded if they are earlier than 15 weeks pregnant or younger than age 18. High-risk subjects cannot participate if their physician does not grant permission for them to participate in the study. Again, the 510(k) summary lists no exclusions for the use of the subject device.
Recruitment methods
* Women age 18 or older with uncomplicated pregnancies will be recruited by placing posters in local perinatal clinics. When prospective subjects call, the study is described to them and they are asked if they have any high-risk conditions that might affect their participation. If any issues arise, Dr. Wakai in consultation with Dr. Strasburger determines whether they are appropriate to study. Informed consent will be obtained at the time of study by Dr. Wakai or one of his associates. Normal subjects will be invited to return for follow up sessions up to 5 times.
* Pregnancies complicated by fetal arrhythmia and or at risk of fetal arrhythmia will be recruited by Dr. Janette Strasburger, Medical College of Wisconsin. She will screen the subjects, explain the procedure, counsel them, and recruit them for the study prior to referring them on to Dr. Wakai. These patients are already being clinically evaluated and it is not anticipated that advertising for participants or posting of flyers will be required. In addition to patients from Madison, Milwaukee and Chicago, high-risk patients from across the country may be enrolled in the study. In these cases the patient's physician has contacted the investigators because he/she believes fMCG may be beneficial for clinical care. These high-risk subjects are screened for appropriateness by Dr. Strasburger, who will consult with the patient's physician in order to determine whether the risk of travel to Madison is reasonable. Informed consent will be obtained at the time of study at the Biomagnetism Lab by Dr. Wakai or one of his associates.
* There are no inclusion or exclusion criteria based on race or ethnicity. Informed Consent
* Informed consent requirements and regulations relating to informed consent will be followed. Informed consent will be obtained prior to performing any study-related activities.
* Prior to signing a consent form, subjects are given a tour of the lab, the experimental procedures are described to them, and their questions are answered. For all subjects, consent and HIPAA authorization will be obtained by the PI or one of his representatives at the time of study.
Subject preparation
The subject is asked to remove all metal and magnetic objects (e.g. watches, glasses, jewelry, coins) from her person and change into a patient gown. The subject lies on a patient table in a magnetically shielded room throughout the study. An intercom system allows verbal communication at all times and the subject can be observed through an aperture in the room.
Data Acquisition
Ultrasound. An ultrasound exam will be performed by Dr. Strasburger to assess the heart rhythm of the fetus. The exam will be performed according American Society of Echocardiography (ASE) standards for fetal arrhythmia.
fMCG recording. The SQUID detector is placed over the maternal abdomen near the location of the fetal heart. Several 10-minute recordings are made, repositioning the detector between recordings,
Data analysis.
fMCG
After the recordings are digitally filtered to band-limit the signal, signal processing techniques are applied to remove maternal interference. Maternal heart rate is evaluated. The fetal QRS complexes are detected using autocorrelation. Fetal heart rate tracings are calculated from the RR intervals, and actogram tracings are derived from the instantaneous amplitude of the QRS complex, which changes in response to fetal trunk movement. Averaged fMCG waveforms are computed to increase the signal-to-noise ratio. The data are organized into a report. The reports consist of 1) fetal heart rate and actogram tracings, 2) averaged fMCG waveforms, and 3) fMCG rhythm strips. Rhythm interpretation and clinical diagnosis is based on assessment of these data. The fetal heart rate tracings are used to identify periods of abnormal heart rate, corresponding to bradycardia, tachycardia, or ectopy. The fetal heart rate tracings and actograms can be used to assess heart rate reactivity, which is an association between fetal heart rate acceleration and fetal movement. The fetal heart rate tracings can also be used to assess fetal heart rate variability with high precision.
The averaged waveforms are used to measure waveform intervals-PR, QRS, QTc-which can be used to detect abnormalities in AV conduction, ventricular conduction, and repolarization. The intervals are defined the same way as for the ECG: PR interval is measured from the onset of the P-wave to the onset of the QRS complex; QRS interval measures the duration of the QRS complex; QT interval is measured from the onset of the QRS complex to the termination of the T-wave; and the corrected QT interval, QTc, corrects the QT interval for heart rate by dividing by the square root of the RR interval, measured in seconds. The intervals are compared with historical norms. The rhythm strips are used to diagnose rhythm abnormalities in a similar way as an ECG, based on the timing and morphology of the waveform components.
For fetal arrhythmia and other high-risk subjects, the results will be interpreted by Dr. Strasburger, who sends the report to and discusses the results with the referring physician. In order to protect the confidentiality of the subject, the data will be sent in electronic files labeled with an identification number, but the referring physician and Drs. Strasburger will be made aware of the identity of the subject (patient).
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 purpose of the proposed study is to utilize fMCG, the magnetic analog of fetal ECG, to characterize the heart rate and rhythm patterns of fetuses with fetal arrhythmia or at risk of fetal arrhythmia. The study is not intended to be a pivotal study. The subject device is already cleared for clinical use for recording of fetal rhythm; however, FDA has determined that an IDE is required for the proposed study. The study is expected to last approximately 6 years
The Tristan 624 is housed within the magnetically shielded room in the Biomagnetism Laboratory located within the Wisconsin Institutes for Medical Research on the University of Wisconsin-Madison campus.
Protocol
Facilities
The UW Biomagnetism Lab is located within the Wisconsin Institutes for Medical Research, a state-of-the-art translational research facility adjacent to UW Hospitals and Clinics. The study sponsor, Ronald Wakai, PhD, Professor of Medical Physics, is the Laboratory Director. Within the laboratory, medical supervision is provided by Janette Strasburger, MD. The facility is directly adjacent to UW Hospital. An emergency response plan is in place for the facility and for the Biomagnetism Lab. In the study of over 700 pregnancies thus far, the emergency response plan has not been needed.
Subject cohort
The investigators plan to study a total of 300 subjects: 75 will be pregnant women with uncomplicated pregnancies and 225 will be pregnant women with pregnancies complicated by fetal arrhythmia or a condition that puts the fetus at risk of fetal arrhythmia. These cases are considered "high-risk" due to the presence of or risk of serious arrhythmia to the fetus. It will take approximately 5 years from the start of data collection to recruit the subjects and collect and analyze the data. 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.
Inclusion criteria for normal subjects. The pregnant women subjects must be at least 12 weeks pregnant and at least 18 years old. They must have uncomplicated pregnancies.
Exclusion criteria for normal subjects. The pregnant women subjects will be excluded if they are earlier than 12 weeks pregnant or younger than age 18. The 510(k) summary lists no exclusions for the use of the subject device.
Inclusion criteria for high-risk subjects. The pregnant women subjects must be at least 15 weeks pregnant and at least 18 years old. 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 or tachycardia and frequent and/or complex ectopy (irregular rhythm) 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 for high-risk subjects. The pregnant women subjects will be excluded if they are earlier than 15 weeks pregnant or younger than age 18. High-risk subjects cannot participate if their physician does not grant permission for them to participate in the study. Again, the 510(k) summary lists no exclusions for the use of the subject device.
Recruitment methods
* Women age 18 or older with uncomplicated pregnancies will be recruited by placing posters in local perinatal clinics. When prospective subjects call, the study is described to them and they are asked if they have any high-risk conditions that might affect their participation. If any issues arise, Dr. Wakai in consultation with Dr. Strasburger determines whether they are appropriate to study. Informed consent will be obtained at the time of study by Dr. Wakai or one of his associates. Normal subjects will be invited to return for follow up sessions up to 5 times.
* Pregnancies complicated by fetal arrhythmia and or at risk of fetal arrhythmia will be recruited by Dr. Janette Strasburger, Medical College of Wisconsin. She will screen the subjects, explain the procedure, counsel them, and recruit them for the study prior to referring them on to Dr. Wakai. These patients are already being clinically evaluated and it is not anticipated that advertising for participants or posting of flyers will be required. In addition to patients from Madison, Milwaukee and Chicago, high-risk patients from across the country may be enrolled in the study. In these cases the patient's physician has contacted the investigators because he/she believes fMCG may be beneficial for clinical care. These high-risk subjects are screened for appropriateness by Dr. Strasburger, who will consult with the patient's physician in order to determine whether the risk of travel to Madison is reasonable. Informed consent will be obtained at the time of study at the Biomagnetism Lab by Dr. Wakai or one of his associates.
* There are no inclusion or exclusion criteria based on race or ethnicity. Informed Consent
* Informed consent requirements and regulations relating to informed consent will be followed. Informed consent will be obtained prior to performing any study-related activities.
* Prior to signing a consent form, subjects are given a tour of the lab, the experimental procedures are described to them, and their questions are answered. For all subjects, consent and HIPAA authorization will be obtained by the PI or one of his representatives at the time of study.
Subject preparation
The subject is asked to remove all metal and magnetic objects (e.g. watches, glasses, jewelry, coins) from her person and change into a patient gown. The subject lies on a patient table in a magnetically shielded room throughout the study. An intercom system allows verbal communication at all times and the subject can be observed through an aperture in the room.
Data Acquisition
Ultrasound. An ultrasound exam will be performed by Dr. Strasburger to assess the heart rhythm of the fetus. The exam will be performed according American Society of Echocardiography (ASE) standards for fetal arrhythmia.
fMCG recording. The SQUID detector is placed over the maternal abdomen near the location of the fetal heart. Several 10-minute recordings are made, repositioning the detector between recordings,
Data analysis.
fMCG
After the recordings are digitally filtered to band-limit the signal, signal processing techniques are applied to remove maternal interference. Maternal heart rate is evaluated. The fetal QRS complexes are detected using autocorrelation. Fetal heart rate tracings are calculated from the RR intervals, and actogram tracings are derived from the instantaneous amplitude of the QRS complex, which changes in response to fetal trunk movement. Averaged fMCG waveforms are computed to increase the signal-to-noise ratio. The data are organized into a report. The reports consist of 1) fetal heart rate and actogram tracings, 2) averaged fMCG waveforms, and 3) fMCG rhythm strips. Rhythm interpretation and clinical diagnosis is based on assessment of these data. The fetal heart rate tracings are used to identify periods of abnormal heart rate, corresponding to bradycardia, tachycardia, or ectopy. The fetal heart rate tracings and actograms can be used to assess heart rate reactivity, which is an association between fetal heart rate acceleration and fetal movement. The fetal heart rate tracings can also be used to assess fetal heart rate variability with high precision.
The averaged waveforms are used to measure waveform intervals-PR, QRS, QTc-which can be used to detect abnormalities in AV conduction, ventricular conduction, and repolarization. The intervals are defined the same way as for the ECG: PR interval is measured from the onset of the P-wave to the onset of the QRS complex; QRS interval measures the duration of the QRS complex; QT interval is measured from the onset of the QRS complex to the termination of the T-wave; and the corrected QT interval, QTc, corrects the QT interval for heart rate by dividing by the square root of the RR interval, measured in seconds. The intervals are compared with historical norms. The rhythm strips are used to diagnose rhythm abnormalities in a similar way as an ECG, based on the timing and morphology of the waveform components.
For fetal arrhythmia and other high-risk subjects, the results will be interpreted by Dr. Strasburger, who sends the report to and discusses the results with the referring physician. In order to protect the confidentiality of the subject, the data will be sent in electronic files labeled with an identification number, but the referring physician and Drs. Strasburger will be made aware of the identity of the subject (patient).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Fetal Arrhythmia
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_CONTROL
Study Time Perspective
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-risk pregnancy
abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm
fetal MCG
Intervention Type
DEVICE
assess fetal heart rate and rhythm
Uncomplicated pregnancy
uncomplicated pregnancy
fetal MCG
Intervention Type
DEVICE
assess fetal heart rate and rhythm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fetal MCG
assess fetal heart rate and rhythm
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* uncomplicated pregnancy at gestational age \>12 weeks
* pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age \>15 weeks
* pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age \>15 weeks
Exclusion Criteria
* uncomplicated pregnancy \<12 weeks gestation
* pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age \<15 weeks
* pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age \<15 weeks
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ronald Wakai, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Wisconsin-Madison
Madison, Wisconsin, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Wacker-Gussmann A, Tardelli G, Cuneo BF, Strasburger JF, Wakai RT. Fetal Conduction Disease and Arrhythmia in Ebstein's Anomaly and Tricuspid Valve Dysplasia Assessed by Fetal Magnetocardiography. J Am Heart Assoc. 2025 Aug 5;14(15):e043614. doi: 10.1161/JAHA.125.043614. Epub 2025 Jul 29.
Reference Type
DERIVED
Strand S, Strasburger JF, Cuneo BF, Wakai RT. Complex and Novel Arrhythmias Precede Stillbirth in Fetuses With De Novo Long QT Syndrome. Circ Arrhythm Electrophysiol. 2020 May;13(5):e008082. doi: 10.1161/CIRCEP.119.008082. Epub 2020 May 18.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A534800
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICAL PHYSICS
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 7/16/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2013-0362 Stage 3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Non-invasive Mapping Using Ultra-high Frequency Electrocardiography
NCT04537455
COMPLETED
NA
MCG In Long QT Syndrome
NCT07270211
NOT_YET_RECRUITING
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
NCT06392555
COMPLETED
Cardiac Elastography to Determine Strain and Strain Rates in the Heart
NCT00205387
COMPLETED
Measurement of the Electromechanical Window to Improve the Diagnosis of Congenital Long QT Syndrome
NCT04328376
COMPLETED
NA
Efficacy Rate of Unipolar Polarity Switch for Lesion Assessment in Pulmonary Vein Isolation
NCT05464537
TERMINATED
NA
NIRS in Congenital Heart Defects - Correlation With Echocardiography
NCT04106479
RECRUITING
UHF ECG in LBBB and Response to CRT Prediction
NCT07057544
RECRUITING
NA
Magnetocardiography (MCG) Parameters in the Prediction of Future ICD Therapy
NCT04352816
ACTIVE_NOT_RECRUITING
NA
Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
NCT04657835
NOT_YET_RECRUITING
NA
Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios
NCT05737043
COMPLETED
NA
The Right Heart During and After Pregnancy - an Echocardiographic Study
NCT03402971
UNKNOWN
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
NCT06497205
RECRUITING
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
NCT05423665
RECRUITING
The Doppler Feasibility Study
NCT06093373
COMPLETED
An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs
NCT05734664
COMPLETED
NA
Real-time 3-Dimensional Echocardiography for Assessment of Cardiac Function and Congenital Heart Disease
NCT01300221
WITHDRAWN
PPG to Predict Ejection Fraction and Other Echographic Data in the General Population
NCT04843371
RECRUITING
Evaluation of Left Ventricular Volumes by Real-Time 3-Dimensional Echocardiography
NCT00001740
COMPLETED
Prospective Evaluation of Univentricular Hearts
NCT05620030
RECRUITING
NA
Fetal Cardiac Function Evaluation With aCMQ-Strain Fetal (STRAIN)
NCT03536000
UNKNOWN
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
NCT01662141
COMPLETED
Cardiac Hemodynamics During Left Ventricular Assist
NCT06115096
RECRUITING