AUSCULTECH DX LLC — Department of Health and Human Services STTR Phase I: NICHD

Description

Project Summary There are 24,000 stillbirths per year in the United States, and 2.6 million stillbirths per year worldwide, with no significant decrease in the last decade. Abnormal fetal heart rhythms, such as long QT syndrome, are thought to play an important role in these deaths, and may cause 3- 10% of unexplained stillbirths. This is in addition to known fetal arrhythmias, which affect 1-3% of pregnancies per year. A magnetocardiogram is the gold standard to detect these disorders, but is not portable or practical for widespread use. Other available tools such as ultrasound and cardiotocography cannot measure the intervals needed to diagnose and guide management of life threatening arrhythmias. The ideal tool for diagnosing and guiding therapy for arrhythmias is an electrocardiogram (ECG). Unfortunately, clinicians do not widely use the existing fetal electrocardiogram (fECG) devices for a variety of reasons: they do not work throughout all of gestation, can miss brief arrhythmias, have a delay between the actual rhythm and displayed rhythm, do not work in multiple gestations, and lack resolution of important intervals. Our team has refined a prototype fECG during an ongoing R21 funded study. This proposal will build on our preliminary work to create a compact version of the fECG which can be utilized more widely in ambulatory settings. In this proposal we aim to: 1. Develop a compact amplifier system 2. Develop a new user interface 3. Pilot test the new system in a cohort of ten pregnant women carrying fetuses 22-40weeks gestation to determine whether it is comparable to or superior to the currentsystem in fECG quality and CTI measurements. If successful, fetal cardiologists could use this tool to diagnose and treat known and latent fetal arrhythmias. Globally, it could serve as a low cost tool to screen for arrhythmias that lead to stillbirth and to monitor fetuses for compromise during surgery, maternal medication use, and fetal interventions. Clinically implementing this critical diagnostic tool will be a landmark in the field of fetal cardiology.