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Fetal Cardiac MR Images to Improve the Diagnostic Accuracy of Prenatal Imaging for Congenital Heart Disease

Overview

About this study

The purpose of this study is to test an FDA-cleared, MR-compatible, fetal cardiac gating device, called Smart-sync (Northh Medical) for the development and acquisition of gated MR images of the fetal cardiac structures. Images will be compared to standard fetal ultrasound and fetal echocardiogram images to determine if fetal cardiac MR helps to identify better fetal cardiac anatomy.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  •  Pregnant women (over 18 years of age) who are already undergoing a clinically-indicated fetal ultrasound or fetal echocardiogram may choose to consent to participate. 

Exclusion Criteria:

  • Pregnant women (less than 18 years of age) and those who do not consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/19/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kelly Horst, M.D.

Open for enrollment

Contact information:

Lesley Riess R.T.(R)(CT)

Riess.Lesley@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20570162

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