MyHeartSentinel wearable system for remote heart monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Caen University Hospital
  Caen, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.