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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT02344420
Eligibility Criteria:
Inclusion Criteria:
* Indication for a "De Novo" implantation of a CRT device according to ESC Guidelines
* Understand the nature of the procedure
* Give written informed consent
Exclusion Criteria:
* CRT Device replacements
* CRT upgrades
* Permanent / Persistent Atrial Fibrillation
* Age\< 18 years
* Pregnant and breastfeeding women
* Subjects with irreversible brain damage from pre existing cerebral disease
* Subjects with acutely de compensated heart failure
* NYHA Class IV Heart Failure
* Heart transplantation six months prior to the enrolment or expected within next 3 months.
* Cardiac surgery 3 months prior to the enrolment or planned within next 3 months.
* Have a life expectancy of less than 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02344420
Study Brief:
Protocol Section:
NCT02344420