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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT07281859
Eligibility Criteria:
Inclusion Criteria:
* The patient has already received a de novo ICD (DR or DX) or CRT-D within no more than one year, according to guidelines, equipped with atrial sensing and a Home Monitoring system.
* Documentation of heart failure of ischemic or non-ischemic origin.
* At the time of device implantation: ejection fraction ≤35% and NYHA Class II or III.
* Sinus rhythm.
* Age ≥18 years.
* The patient has signed the informed consent for participation.
Exclusion Criteria:
* Patients who have received the implantable device as a replacement or upgrade of a previous one.
* Patients who have received the device more than one year ago.
* At the time of enrollment: patient with HeartInsight previously activated.
* Permanent or long-standing atrial fibrillation.
* Sinus node disease with indication for atrial pacing.
* At the time of enrollment: NYHA Class IV.
* Planned cardiac surgery within three months following enrollment.
* Life expectancy of less than one year.
* Unstable residence or insufficient GSM coverage at the patient's home.
* Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07281859
Study Brief:
Protocol Section:
NCT07281859