About this trial
The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic resonance (CMR) imaging findings. The study aims to obtain usable ICG test data on six patients with aortic stenosis who have recently undergone CMR scans with late gadolinium enhancement, and who do not have a history of myocardial infarction or cardiac amyloidosis. The hypothesis to be tested is that the HYPERGRAPH can accurately detect left ventricular decompensation associated with replacement fibrosis obtained from CMR imaging.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Male or female at least 18 years of age.
No prior history of myocardial infarction or cardiac amyloidosis.
Recent CMR scan with late gadolinium enhancement or scheduled for CMR scan with late gadolinium enhancement.
Moderate aortic stenosis and no replacement fibrosis OR Moderate aortic stenosis and symptoms who has replacement fibrosis OR Severe aortic stenosis with replacement fibrosis prior to aortic valve replacement.
Disqualifiers
• Under 18 years of age
Pregnant or breastfeeding women
Unable to consent
Prisoners
Trial design
Sequential
Treatments tested in this trial
Impedance Cardiography Upright/Supine Test
DeviceThis ICG upright/supine test is a comparison of \[dZ/dt\]max in the supine position to \[dZ/dt\]max in an upright position for assessing decompensation.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between ICG decompensation detection and replacement fibrosis measured by CMR scan
Look for a negative ICG test for decompensation correlating with a CMR scan indicating a very low extracellular volume and a positive ICG test for decompensation correlating with a CMR scan indicating a very high extracellular volume.
Sponsors and contacts
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Dermed Diagnostics, Inc.
Lead sponsor
Northwestern University
Collaborator