Comparison of a new ultrasound device for imaging congenital heart disease
RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
This study is testing a new portable ultrasound device to see if it can quickly and safely capture heart images in babies under one year old, comparing the results to standard imaging methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06281639 on ClinicalTrials.gov |
What this trial studies
The RAPID ultrasound is a portable imaging device designed to capture a single image of the heart from the subcostal region in under one minute. It is intended for patients under one year old who are receiving care at Masonic Children's Hospital or the Masonic Children's Heart Center clinic. The images obtained from the RAPID device will be compared to those from standard clinical imaging, with both sets of images securely stored for review by independent cardiologists. This observational study aims to evaluate the effectiveness and safety of the RAPID device in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under one year old receiving care at Masonic Children's Hospital or the Masonic Children's Heart Center clinic.
Not a fit: Patients who are medically unstable, on ECMO, or have open chest conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide faster and safer imaging for infants with congenital heart disease.
How similar studies have performed: While this approach is innovative, it is not clear if similar studies have shown success, as this specific device is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \<1 years old * Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU Exclusion Criteria: * Open Chest * On ECMO * Deemed medically unstable by care team * Cardiology, ICU, hospitalist or bedside nurse concerns
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Gwenyth Fischer, MD — University of Minnesota
- Study coordinator: Gwenyth Fischer, MD
- Email: fisch662@umn.edu
- Phone: 6126256678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.