Electrophysiology of Fetal Arrhythmia
fMCG
6 other identifiers
observational
450
1 country
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 the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedStudy Start
First participant enrolled
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
May 5, 2026
April 1, 2026
10.3 years
February 2, 2017
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rhythm assessment
fetal MCG rhythm assessment
after 15 weeks gestation
Study Arms (2)
High-risk pregnancy
abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm
Uncomplicated pregnancy
uncomplicated pregnancy
Interventions
Eligibility Criteria
Uncomplicated pregnancies and pregnancies complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin-Madison
Madison, Wisconsin, 53705, United States
Related Publications (2)
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.
PMID: 40728160DERIVEDStrand 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.
PMID: 32421437DERIVED
Biospecimen
fetal magnetocardiography and fetal echocardiography recordings
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Wakai, PhD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 8, 2017
Study Start
February 7, 2017
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share