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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • 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.

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Arthur P DeMarzo, MSc
ademarzo.dermed@att.net
1-630-668-4644
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 6
Treatments
Experimental: Impedance cardiography test
The ICG upright/supine test, using the HYPERGRAPH, will be used to show the difference in the compensatory response between normal LV function and decompensation in HF.
Sponsors
Collaborators: Northwestern University
Leads: Dermed Diagnostics, Inc.

This content was sourced from clinicaltrials.gov