UltraTrac for Congenital Heart Disease

(UltraTrac Trial)

This trial tests UltraTrac, a new wearable device designed to monitor heart function in individuals with congenital heart disease. The researchers aim to determine if UltraTrac can accurately measure cardiac output compared to standard methods such as cardiac MRI or catheterization. The trial targets individuals with congenital heart conditions who are already scheduled for these standard procedures or are in the cardiac intensive care unit. Participants should have a diagnosis such as a heart valve issue or a heart defect and be receiving specific heart-related treatments. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance heart monitoring technology.

A previous study identified the UltraTrac device as low-risk. It is noninvasive, meaning it doesn't enter the body or pose serious risks to users. The device employs methods like impedance cardiography and carotid Doppler ultrasound to assess heart function without surgery or implants.

The trial is labeled "Not Applicable" for phases, indicating that UltraTrac is in an early testing stage. This stage typically focuses on verifying the device's functionality rather than extensively testing its safety. Generally, noninvasive devices like this are well-tolerated because they don't physically enter the body or alter its function.

Researchers are excited about UltraTrac because it offers a new way to monitor heart function in patients with congenital heart disease. Unlike traditional methods like thermodilution and direct Fick measurements, UltraTrac provides real-time, non-invasive monitoring. This technique allows for quicker adjustments in treatment, especially during procedures like cardiac catheterization or MRI and in intensive care settings. By potentially enhancing the accuracy and speed of cardiac output assessments, UltraTrac could improve patient outcomes and streamline clinical care.

Research has shown that UltraTrac is a new device designed to monitor heart function in people with congenital heart disease. It uses impedance cardiography and carotid Doppler ultrasound to estimate how well the heart pumps blood. This noninvasive method does not involve surgery or inserting anything into the body. In this trial, participants will join different arms where UltraTrac measurements will be compared with standard methods like cardiac catheterization, MRI, or clinical hemodynamic assessments in the cardiac intensive care unit. Although data on UltraTrac's effectiveness in humans is limited, early signs suggest it could provide a useful, ongoing way to track heart health without invasive procedures.⁶⁷⁸⁹¹⁰