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Electrophysiology of Fetal Arrhythmia (fMCG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03047161
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : June 16, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Fetal Arrhythmia Device: fetal MCG

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Electrophysiology of Fetal Arrhythmia
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
High-risk pregnancy
abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm
Device: fetal MCG
assess fetal heart rate and rhythm

Uncomplicated pregnancy
uncomplicated pregnancy
Device: fetal MCG
assess fetal heart rate and rhythm




Primary Outcome Measures :
  1. Rhythm assessment [ Time Frame: after 15 weeks gestation ]
    fetal MCG rhythm assessment


Biospecimen Retention:   Samples Without DNA
fetal magnetocardiography and fetal echocardiography recordings


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Uncomplicated pregnancies and pregnancies complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047161


Contacts
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Contact: Ronald Wakai, PhD 608-265-4988 rtwakai@wisc.edu
Contact: Janette Strasburger, MD jstrasburger@chw.org

Locations
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United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Ronald Wakai, Ph.D.    608-265-4988    rtwakai@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ronald Wakai, PhD University of Wisconsin, Madison
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03047161    
Other Study ID Numbers: 2013-0362 Stage 3
A534800 ( Other Identifier: UW Madison )
SMPH\MEDICAL PHYSICS ( Other Identifier: UW Madison )
2R01HL063174-19A1 ( U.S. NIH Grant/Contract )
Protocol Version 5/11/2022 ( Other Identifier: UW Madison )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Wisconsin, Madison:
magnetocardiography
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes