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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00711893
Eligibility Criteria:
Inclusion Criteria:
* indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines
* Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
* Geographically stable patients who are available for follow-up at a study centre
* Age 18 or above, or of legal age to give informed consent specific to national law
Exclusion Criteria:
Inability or refusal to sign the Patient Informed Consent
* Pregnant or planning to become pregnant
* Replacement device
* Enrolment in another clinical trial, study or evaluation
* Estimated life expectancy of less than six months per discretion of physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00711893
Study Brief:
Protocol Section:
NCT00711893