Heart FailureASEMC-DRNCT07345533
EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE
A study testing MYHEARTSENTINEL SYSTEM cutaneous DEVICE in people with Heart Failure and Telemonitoring, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Telemonitoring, Right Heart Catheterisation
- What is being tested?
- MYHEARTSENTINEL SYSTEM cutaneous DEVICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2025to 17 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
Rémi SABATIER, MD, +33231063050, sabatier-r@chu-caen.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Heart Failure, Telemonitoring, Right Heart Catheterisation
- Being tested
- MYHEARTSENTINEL SYSTEM cutaneous DEVICE
- Keywords
- Telemonitoring, heart failure, right heart catheterisation, acute heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYHEARTSENTINEL SYSTEM cutaneous DEVICEDevice
MYHEARTSENTINEL SYSTEM cutaneous DEVICE
| Study group | Role | What they receive |
|---|---|---|
| Standard of care plus MYHEARTSENTINEL SYSTEM device | Experimental | Not described Receives: Device: MYHEARTSENTINEL SYSTEM cutaneous DEVICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG modification (yes/no)
Identification of parameters/indicators that vary in relation to biological and/or hemodynamic changes and/or the patient's clinical condition.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start17 Jul 2025
- Primary completion17 Mar 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345533
- Sponsor's protocol ID
- 24-0232
- Acronym
- ASEMC-DR
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07345533
- Acronym / sponsor ID
- ASEMC-DR / 24-0232
- Conditions
- Heart Failure, Telemonitoring, Right Heart Catheterisation
- Keywords
- Telemonitoring, heart failure, right heart catheterisation, acute heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus MYHEARTSENTINEL SYSTEM device | Experimental | Device: MYHEARTSENTINEL SYSTEM cutaneous DEVICE |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MYHEARTSENTINEL SYSTEM cutaneous DEVICEMYHEARTSENTINEL SYSTEM cutaneous DEVICE | Device | Standard of care plus MYHEARTSENTINEL SYSTEM device |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MYHEARTSENTINEL SYSTEM cutaneous DEVICE in people with Heart Failure and Telemonitoring, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG modification (yes/no) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.