Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07345533
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07345533
Study Brief:
Protocol Section:
NCT07345533