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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01154205
Eligibility Criteria:
Inclusion Criteria:
* Approved indication for ICD or CRTD
* Implanted with or replaced with a Biotronik Lumax device
* Patient willing and able to sign consent form
* Willing and able to attend clinic visits and follow up schedule
* Transmission of more than 80% at 3-month follow up
* Patient older than 18 years
Exclusion Criteria:
* no indication for ICD or CRTD implant
* Life expectancy shorter than 12 months
* Pregnancy
* Participation in other clinical studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01154205
Study Brief:
Protocol Section:
NCT01154205