NCT03541291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

5.8 years

First QC Date

May 18, 2018

Last Update Submit

March 22, 2024

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Comparison between fetal MRI and fetal echocardiography

    Anatomic 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.

    within 2 weeks of participation in the study

Study Arms (1)

SMART-SYNC LM03

EXPERIMENTAL

All participants

Device: SMART-SYNC LM03

Interventions

SMART-SYNC LM03DEVICE

Doppler ultrasound cardiac gating device for fetal MRI application

SMART-SYNC LM03

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mike Seed, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Qualified Investigator

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 30, 2018

Study Start

May 30, 2018

Primary Completion

March 22, 2024

Study Completion

March 22, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)