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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00930969
Eligibility Criteria:
Inclusion Criteria:
* Subject is indicated for an ICD implantation
* AND subject must meet ONE of the following:
* Prior acute coronary event
* Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
* Multivessel disease
* Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization
Exclusion Criteria:
* Subject is currently dependent on ventricular pacing
* Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
* Subject has chronic Atrial Fibrillation (AF)
* Subject has dementia
* Subject is indicated for a single chamber device
* Subject requires a right sided or abdominal ICD implant
* Subject is pregnant or in fertile age without secure birth control
* Subject has New York Heart Association (NYHA) class IV or refractory heart failure
* Subject is not expected to survive greater than 12 months
* Subject is participating in other confounding research studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00930969
Study Brief:
Protocol Section:
NCT00930969