Fetal ArrhythmiaNCT01903564
Fetal and Neonatal Magnetophysiology
An observational study of Fetal Arrhythmia and Abnormality in Fetal Heart Rate or Rhythm, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Arrhythmia, Abnormality in Fetal Heart Rate or Rhythm, Long QT Syndrome
- What is being tested?
- magnetocardiography, postnatal ECG and fetal echocardiography
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
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.
- Being tested
- magnetocardiography, postnatal ECG, fetal echocardiography
- Keywords
- fetus, fetal arrhythmia, fetal heart rate, long QT syndrome
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetocardiographyDevice
Also called MCG, fetal magnetocardiography
recording of magnetic heart activity
postnatal ECGDevice
Also called electrocardiography
postnatal ECG
fetal echocardiographyDevice
Also called Doppler ultrasound, M-mode ultrasound, 2d ultrasound
fetal echocardiography
| Study group | Role | What they receive |
|---|---|---|
| normal | pregnant women with uncomplicated pregnancies Receives: Device: magnetocardiography; Device: fetal echocardiography | |
| high-risk | pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia Receives: Device: magnetocardiography; Device: postnatal ECG; Device: fetal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Experiencing Symptoms
Percentage of subjects experiencing symptoms
Measured: 15-40 weeks' gestation
Percentage of Subjects Experiencing Adverse Events Unrelated to Device
Percentage of subjects experiencing adverse events unrelated to device
Measured: 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)
Measured: Birth to age 1 week
Percentage of Subjects Experiencing Adverse Events Related to Device
Percentage of Subjects Experiencing Adverse Events Related to Device
Measured: 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
Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG
Measured: 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
Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG
Measured: 15 weeks' gestation to birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fetal ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Shared Medical Technology, Inc., Medical College of Wisconsin, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ronald Wakai, Ph.D., Principal investigator, University of Wisconsin, MadisonJanette Strasburger, M.D., Study director, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903564
- Sponsor's protocol ID
- 2013-0362
- Other IDs
- R01HL063174
- Status last verified
- May 2019
- First submitted
- 11 Jul 2013
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal and Neonatal Magnetophysiology
- ClinicalTrials.gov ID
- NCT01903564
- Acronym / sponsor ID
- 2013-0362
- Keywords
- fetus, fetal arrhythmia, fetal heart rate, long QT syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Shared Medical Technology, Inc., Medical College of Wisconsin, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal | – | Device: magnetocardiography, Device: fetal echocardiographypregnant women with uncomplicated pregnancies |
| high-risk | – | Device: magnetocardiography, Device: postnatal ECG, Device: fetal echocardiographypregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetocardiographyAlso: MCG, fetal magnetocardiographyrecording of magnetic heart activity | Device | high-risk, normal |
| postnatal ECGAlso: electrocardiographypostnatal ECG | Device | high-risk |
| fetal echocardiographyAlso: Doppler ultrasound, M-mode ultrasound, 2d ultrasoundfetal echocardiography | Device | high-risk, normal |
Primary outcome
Percentage of Subjects Experiencing Symptoms
Time frame: 15-40 weeks' gestation
Percentage of subjects experiencing symptoms
Percentage of Subjects Experiencing Adverse Events Unrelated to Device
Time frame: 15 weeks' gestation till up to 1 month after birth
Percentage of subjects experiencing adverse events unrelated to device
Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome
Time frame: 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)
Percentage of Subjects Experiencing Adverse Events Related to Device
Time frame: 15 weeks' gestation till up to 1 month after birth
Percentage of Subjects Experiencing Adverse Events Related to Device
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Wakai, Ph.D. principal investigator
University of Wisconsin, Madison
Janette Strasburger, M.D. study director
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Arrhythmia and Abnormality in Fetal Heart Rate or Rhythm, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Experiencing Symptoms (time frame: 15-40 weeks' gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.