MyHeartSentinel wearable system for remote heart monitoring
EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE - ANALYSIS OF CARDIAC ELECTROPHYSIOLOGICAL AND MECHANICAL SIGNALS DURING A DECOMPENSATION/RECOMPENSATION EPISODE IN PATIENTS WITH HEART FAILURE IN THE HOSPITAL AND UPON DISCHARGE HOME
This project will test whether wearing the MyHeartSentinel cutaneous device can record electrical and mechanical heart signals in adults hospitalized with decompensated chronic heart failure to help track changes in their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT07345533 on ClinicalTrials.gov |
What this trial studies
The study recruits adults hospitalized for hemodynamic assessment or for congestive decompensation of known chronic heart failure and applies the MyHeartSentinel external cutaneous device to collect continuous electrophysiological and mechanical cardiac signals. Investigators will build a database of those signals and correlate them with biological markers, hemodynamic data, and the patient's clinical status. The goal is to identify signal patterns that change with worsening or improving heart failure and to inform development of automated remote monitoring tools. Data collection occurs at Caen University Hospital using non-invasive wearable sensors during the hospital stay.
Who should consider this trial
Good fit: Adults aged 18–90 with known chronic heart failure who are hospitalized for hemodynamic assessment or for congestive decompensation (with BNP > 400 µg/ml or NT‑proBNP > 1600 µg/ml) are the intended participants.
Not a fit: Patients with decompensation due to active infection requiring antibiotics, recent intravenous inotrope use, ventricular arrhythmias or permanent atrial fibrillation, acute ST‑elevation coronary syndromes, certain structural heart conditions awaiting intervention, or who are pregnant or breastfeeding are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of worsening heart failure and support automated remote monitoring to reduce urgent hospital visits.
How similar studies have performed: Related remote-monitoring approaches, such as implantable pressure monitors and some wearable sensors, have shown promise for detecting worsening heart failure, but combining external electrophysiological and mechanical signal monitoring with automated detection is relatively novel and less proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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, eczema, psoriasis, or other skin conditions at the placement site. * Physical or psychological inability of the patient or caregiver to use the digital medical telemonitoring device and/or its collection accessories, as determined by the physician wishing to include the patient in the medical telemonitoring project; * Patient refusal to transmit the data necessary to monitor the effective use of the DMN and to obtain individualized or national real-life usage results; * Patient refusal to receive therapeutic support.
Where this trial is running
Caen
- Caen University Hospital — Caen, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.