EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE (ASEMC-DR)

January 7, 2026 updated by: University Hospital, Caen

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

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 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:

The study will test the hypothesis that regular, automated remote monitoring of the data collected during the study can identify the risk of decompensation. Ultimately, this approach could improve the management of heart failure by maintaining a state of balance, while reducing the mental burden on patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Caen University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard of care plus MYHEARTSENTINEL SYSTEM device
Device: MYHEARTSENTINEL SYSTEM cutaneous DEVICE
MYHEARTSENTINEL SYSTEM cutaneous DEVICE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECG modification (yes/no)
Time Frame: baseline
Identification of parameters/indicators that vary in relation to biological and/or hemodynamic changes and/or the patient's clinical condition.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2025

Primary Completion (Estimated)

March 17, 2026

Study Completion (Estimated)

March 17, 2027

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0232

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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