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EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE

NCT07345533 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

MYHEARTSENTINEL SYSTEM cutaneous DEVICE

MYHEARTSENTINEL SYSTEM cutaneous DEVICE

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2027-03-17
Completion
2028-03-17

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07345533 on ClinicalTrials.gov