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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT03632057
Eligibility Criteria:
Inclusion Criteria:
* Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks
* Subjects who are willing to be registered on the Merlin.net remote follow-up program
* Subject ≥18 years
* Subjects with life expectancy of at least 1 year
* Subjects who agree to comply with the follow-up program included in this protocol
Exclusion Criteria:
* • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months
* Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
* Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
* Functional NYHA Class IV
* Subjects who are participating in another ICD or CRT-D study
* Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
* Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03632057
Study Brief:
Protocol Section:
NCT03632057