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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT06542133
Eligibility Criteria:
Inclusion Criteria:
* Subject must provide written informed consent prior to any study-related procedure.
* Subject is willing and has consented to study clinical procedure.
* Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
* Subject has an active, appropriately functioning Aveir leadless pacemaker system
* Subject is willing to use the device
Exclusion Criteria:
* Subject is unable to read/write at a sufficient level to provide informed consent.
* Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
* Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06542133
Study Brief:
Protocol Section:
NCT06542133