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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT02969395
Eligibility Criteria:
Inclusion Criteria:
* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Subject is intended to be implanted or is within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system
Exclusion Criteria:
* Subject who is, or will be inaccessible for follow-up at a study site
* Subject with exclusion criteria required by local law (Europe, Central Asia \[ECA\] only)
* Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02969395
Study Brief:
Protocol Section:
NCT02969395