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:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT07247032
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18-85
* Patient diagnosed with a New York Heart Association (NYHA) class II or III
* Patients with left ventricular ejection fraction ≼ 40 %
* Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic)
* Non-activation of others HF multisensor algorithms
* Patient remote monitored on Implicity CIED platform
* Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring
* Patient is willing to be remotely monitored for heart failure
* HF treated according to European Society of Cardiology (ESC) guidelines
Exclusion Criteria:
* Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
* Patients with a life expectancy of less than 12 months
* Patients enrolled in concurrent clinical studies
* Patients with a history of non-compliance with medical care or inability to comply with the study protocol
* Patients already receiving remote monitoring for heart failure
* Pregnant or breastfeeding women
* Subjects under legal protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07247032
Study Brief:
Protocol Section:
NCT07247032