EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE (NCT07345533) | Clinical Trial Compass
RecruitingNot Applicable
EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE
France70 participantsStarted 2025-07-17
Plain-language summary
Background:
Chronic heart failure represents a major public health challenge, affecting approximately 64 million people worldwide and generating high costs in terms of mortality, frequent hospitalizations, and medical expenses. In France, this disease is expected to cause nearly 70,000 deaths and 181,000 hospital admissions in 2022. Current management, based on periodic consultations, fails to effectively prevent acute exacerbations, highlighting the importance of technological solutions such as remote monitoring.
Objective:
This study aims to demonstrate the value of regular monitoring of electrophysiological and mechanical cardiac signals and parameters in patients with chronic heart failure. Its goal is to build a database of signals from an external measuring device (MyHeartSentinel MHS) to identify parameters that evolve in relation to biological and/or hemodynamic changes and/or the patient's clinical status. The results of this study will enable the further development of an automated monitoring solution for heart failure patients to enable early detection and management of decompensation.
Materials and Methods:
A total of 70 patients diagnosed with chronic heart failure will be included, including 30 patients hospitalized for heart failure decompensation and 40 patients hospitalized for hemodynamic assessment. Electrophysiological and cardiac mechanical data will be collected using a skin-based measuring device. These data will then be correlated with biological and/or hemodynamic changes and/or the patient's clinical status. They will contribute to the training of an algorithm to detect the risk of decompensation.
Hypothesis Tested:
Ability of MHS to detect electrophysiological and cardiac mechanical data related to cardiac decompensation, such as cardiac filling pressure.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged between 18 and 90 years
* Affiliated with the social security system.
* Patients who have been informed of the study and have signed informed consent.
* Patients with heart failure and one of the following two criteria:
* Hospitalized for hemodynamic assessment
* Hospitalized in a cardiology unit (ICU or telemetry unit) for congestive decompensation of known heart failure defined by \[8\] minimal dyspnea at rest or during exercise AND an elevation of BNP \> 400 µg/ml or NT-proBNP \> 1600 µg/ml
Exclusion Criteria:
* Patient hospitalized for decompensated heart failure due to an infectious cause requiring antibiotic treatment
* Patient requiring intravenous inotropes within the last 24 hours
* Patient with ventricular arrhythmias or permanent AF
* ACS with ST+ complex complicated by heart failure
* Valvulopathy awaiting interventional management
* Pericardial constriction
* Pregnant or breastfeeding women
* Women of childbearing potential without effective contraception
* Patients under guardianship, curatorship, legal protection, or legal protection.
* Patients already enrolled in an interventional clinical trial that may impact the electrophysiological and cardiac mechanical measurements of the medical device under study. • Inability to position the sensor on the thoracic area of interest
* Patients with open wounds, recent scars, or skin infections at the intended SCOUT device placement site
* Patients suffering from dermatitis, ec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.