Who is eligible for clinical trial NCT07230964?

Participants must meet protocol criteria for Aortic Stenosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07230964 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-30

Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis (NCT07230964)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Dermed Diagnostics, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).

Location: Northwestern University — Chicago, Illinois

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

• 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.

Usually NOT eligible if any of the following apply:

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 other electronic cardiac implant.
Claustrophobic or afraid or small places.
Severe obesity (BMI \> 40) that impairs accurate ICG measurement due to difficulties in electrode placement or excessive impedance.
Active skin conditions, such as rashes, open wound or significant skin sensitivity at the electrode placement sites.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Northwestern University — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗