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NCT01903564 · ClinicalTrials.gov registry record
Fetal and Neonatal Magnetophysiology
A clinical trial of Long QT Syndrome and Fetal Arrhythmia, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 39
- Enrollment target
- 1
- Study location
NCT01903564 is a study of Long QT Syndrome and Fetal Arrhythmia that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 39 participants, below the 676-participant average among 7 other Long QT Syndrome trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01903564, a study of Long QT Syndrome and Fetal Arrhythmia, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 39 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE magnetocardiography
- DEVICE postnatal ECG
- DEVICE fetal echocardiography
Study Locations (1)
Wisconsin
- University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903564
The ClinicalTrials.gov registry entry for NCT01903564 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 676-participant average among 7 other Long QT Syndrome trials with a reported enrollment target (94% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Long QT Syndrome appearing as the primary indexed condition, and to 3 interventions - of which magnetocardiography is the first listed.
NCT01903564 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01903564 about?
NCT01903564 is a clinical study titled "Fetal and Neonatal Magnetophysiology". 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 u...
What is the current status of trial NCT01903564?
This trial is currently completed. The enrollment target is 39 participants. The study started on 2014-03. Estimated completion is 2018-06.
What conditions does trial NCT01903564 study?
This clinical trial studies the following conditions: Long QT Syndrome, Fetal Arrhythmia, Abnormality in Fetal Heart Rate or Rhythm.
What interventions are being tested in trial NCT01903564?
The interventions under investigation include: magnetocardiography (DEVICE), postnatal ECG (DEVICE), fetal echocardiography (DEVICE).
Who is sponsoring clinical trial NCT01903564?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01903564 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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