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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT01774357
Eligibility Criteria:
Inclusion Criteria:
* Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines
* Implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment
* Written informed consent, willingness and ability to comply with the protocol
Exclusion Criteria:
* Age \< 18 years
* Any limitation to contractual capability
* Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
* Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment
* Simultaneous participation in another study
* Life expectancy \< 2 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01774357
Study Brief:
Protocol Section:
NCT01774357