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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT00729703
Eligibility Criteria:
Inclusion Criteria:
* Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
* Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) ≤ 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
* An optimal (as determined by the enrolling physician) medical regimen.
* Patient has received all relevant information on the study, and has signed and dated a consent form.
Exclusion Criteria:
* Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
* Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
* Any contraindication for ICD therapy and the implant of a dual chamber ICD.
* ICD replacement
* Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
* A PR interval \> 250 ms or AR interval \> 300 ms measured at implant.
* Hypertrophic obstructive cardiomyopathy.
* Acute myocarditis.
* Unstable coronary symptoms or myocardial infarction within the last month.
* Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
* Recently performed (in the last month) or planned cardiac surgery
* Already included in another clinical study.
* Life expectancy less than 24 months.
* Inability to understand the purpose of the study or refusal to cooperate.
* Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
* Unavailability for scheduled follow-up at the implanting or cooperating center.
* Age of less than 18 years.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00729703
Study Brief:
Protocol Section:
NCT00729703