Early Feasibility Study of the Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
Dermed Diagnostics, Inc.
Summary
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.
Description
BACKGROUND: The decision to perform transcatheter aortic valve replacement (TAVR) often occurs after there is permanent heart damage. Therefore, there is a need for a novel method of identifying patients with less than severe aortic stenosis who are at imminent risk of heart damage. The concept is that the onset of left ventricular (LV) decompensation is the tipping point that marks the loss of cardiac reserve and the formation of myocardial fibrosis. This is an observational study to gather data pertaining to the possible link between a simple noninvasive test using impedance cardiography (I…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * • 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. * A history of: * 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. * Able to comprehend and provide informed consent in English. * Participants must have intact, healthy skin at the…
Interventions
- DeviceImpedance Cardiography Upright/Supine Test
This 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.
Location
- Northwestern UniversityChicago, Illinois