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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03518658
Eligibility Criteria:
Inclusion Criteria:
* Patient will be/has been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P device compatible with BlueSync™ (both new and replacement devices are allowed)
* Patient must own a smart device (Smartphone or tablet) that meets system requirements and be willing to use during evaluation period
* Patient must be able to complete the required 12-month follow-up after enrollment
* Patients must be of legal age according to local law
Exclusion Criteria:
* Patient unwilling to complete required surveys during 12-month evaluation period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03518658
Study Brief:
Protocol Section:
NCT03518658