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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT00619593
Eligibility Criteria:
Inclusion Criteria:
* Indication for ICD implantation according to MADIT-II:
* Myocardial infarction 30 days or more before implantation
* LVEF of 30% or less within 3 months before implantation
* Angiography within the preceding 12 months
* The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent
Exclusion Criteria:
* Patients with contraindication for ICD implantation
* Conventional ICD indication (i.e. other than MADIT-II)
* Myocardial infarction within the past 30 days
* Coronary revascularisation within the preceding 3 months (i.e., if revascularization has been performed wait at least 3 months until enrolment, given that no appropriate/ inappropriate ICD therapy has occured)
* NYHA functional class IV
* Unexplained syncope within 3 years
* Advanced cerebrovascular disease
* Life expectancy very probably below 12 months
* Pregnant or breast-feeding women
* Age \< 18 years
* Patients who are already enrolled in another study (therapy/intervention phase)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00619593
Study Brief:
Protocol Section:
NCT00619593