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Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03541291
Enrollment
3
Registered
2018-05-30
Start date
2018-05-30
Completion date
2024-03-22
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Brief summary

We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the MRI scanner when to collect pictures of the fetal heart. This will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be important for assessing human fetal heart disease, an active area of research at our institution.

Interventions

DEVICESMART-SYNC LM03

Doppler ultrasound cardiac gating device for fetal MRI application

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* pregnant adults (age 18 and up) with fetus affected by congenital heart disease * singleton pregnancy in their 2nd and 3rd trimesters * scheduled for a clinical fetal ultrasound examination at the Fetal Echocardiography Clinic at SickKids

Exclusion criteria

* claustrophobia * cardiac pacemaker * non-MRI compatible implants * non-singleton pregnancy * obesity (BMI \> 30)

Design outcomes

Primary

MeasureTime frameDescription
Comparison between fetal MRI and fetal echocardiographywithin 2 weeks of participation in the studyAnatomic MR images of the fetal heart will be acquired using prospective gating information from the Doppler ultrasound probe (SMART-SYNC LM03) and used to calculate ejection fraction. These values will be compared with corresponding reference values obtained during the patient's visit to the Fetal Echocardiography Clinic.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026