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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT01143220
Eligibility Criteria:
Inclusion Criteria:
* Implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.
* Geographically stable patients who are available for follow-up at a study center .
* Age 20 years or above.
* Patients, who do receive all leads that are supposed to be used with a certain type of device (i.e. no dual chamber ICD / CRT-D device without an atrial lead or CRT-D devices with only one ventricular lead).
Exclusion Criteria:
* Inability or refusal of the patient to give approval to collect/store/process personal health information at the sponsor.
* Pregnant women or women, planning to become pregnant .
* Any kind of previous CRM device therapy (no replacements, no upgrades, no new implants after complete system removals ).
* Enrolment in another clinical trial or clinical investigation without prior notification of the sponsor .
* Estimated life expectancy of less than six months per judgment of the physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01143220
Study Brief:
Protocol Section:
NCT01143220