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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT00478933
Eligibility Criteria:
Inclusion Criteria:
* Implantation of a market approved Medtronic Dual-chamber ICD with long term clinical trends Cardiac Compass,
* Subjects requiring the implantation of an ICD for primary prevention according to the current AHA/ACC/ESC guidelines,
* Subject able to comply with the Clinical InvestigationPlan,
* Subject is expected to remain available for follow-up visits,
* Subject has signed the informed consent form within 10 days of implant,
* The system implanted for this study is the first ICD implant for patient.
Exclusion Criteria:
* Women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
* Subject is enrolled in a concurrent study that may confound the results of this study,
* Subject has a life expectancy less than two years,
* Subject is post heart transplant or awaiting heart transplantation,
* Subject is anticipated to demonstrate poor compliance,
* Subjects with syndromes known to be associated with ion channel pathologies such as:
* Long- or short-QT Syndrome
* Brugada Syndrome
* Catecholaminergic Polymorphic Ventricular Tachycardia (CPTV ).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00478933
Study Brief:
Protocol Section:
NCT00478933