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Recruiting NCT07230964

Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis

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Trial Parameters

Condition Aortic Stenosis
Sponsor Dermed Diagnostics, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 6
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-10
Completion 2026-10-23
Interventions
Impedance Cardiography Upright/Supine Test

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Brief 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.

Eligibility Criteria

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 electrode application sites. Exclusion Criteria: * • Under 18 years of age * Pregnant or breastfeeding women * Unable to consent * Prisoners * History of myocardial infarction * History of cardiac amyloidosis * Patients with any metal or implant such as IUD, braces, metal fragments implants in the eye, pacemakers (especially Minute Ventilation pacemakers with the MV function activated) defibrillators, or any o

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