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New treatment option for Heart Failure
Official title EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE
ClinicalTrials.gov ID: NCT07345533
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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
You likely can't join if
- 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 treatment management
- Pericardial constriction
See the full eligibility 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...
- 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 treatment 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 treatment 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.