NCT07230964 Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
| NCT ID | NCT07230964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dermed Diagnostics, Inc. |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2026-10-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2026-04-30 with a primary completion date of 2026-10-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07230964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07230964 currently recruiting?
Yes, NCT07230964 is actively recruiting participants. Contact the research team at ademarzo.dermed@att.net for enrollment information.
Where is the NCT07230964 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07230964 clinical trial?
NCT07230964 is sponsored by Dermed Diagnostics, Inc.. The trial plans to enroll 6 participants.