RecruitingNot ApplicableNCT07345533

EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE

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


Sponsor

University Hospital, Caen

Enrollment

70 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable sensor device called MyHeartSentinel, designed to monitor the heart and detect early signs that heart failure is getting worse — before symptoms become severe enough to require hospitalization. Participants will use the device at home so doctors can monitor them remotely. **You may be eligible if...** - You are 18–90 years old - You have been diagnosed with heart failure - You are currently hospitalized either for a heart check-up (hemodynamic assessment) or because your heart failure has become worse (with shortness of breath and elevated heart failure markers in your blood) **You may NOT be eligible if...** - Your heart failure is caused by an infection requiring antibiotics - You needed IV drugs to strengthen your heart in the past 24 hours - You have certain heart rhythm problems (ventricular arrhythmia or permanent AFib) - You have had a recent heart attack with complications - You have a valve problem awaiting a procedure - You are pregnant or breastfeeding - You have active skin problems (wounds, eczema, psoriasis) where the device would be placed - You are enrolled in another trial that may affect results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMYHEARTSENTINEL SYSTEM cutaneous DEVICE

MYHEARTSENTINEL SYSTEM cutaneous DEVICE


Locations(1)

Caen University Hospital

Caen, France

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NCT07345533


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