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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT07005232
Eligibility Criteria:
Inclusion Criteria:
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.
* Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study
Exclusion Criteria:
* Patient who is, or is expected to be, inaccessible for follow-up
* Patient is excluded by local local law
* Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the Product Surveillence Registyr (PSR) results
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07005232
Study Brief:
Protocol Section:
NCT07005232