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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT07258602
Eligibility Criteria:
Inclusion Criteria:
* Adult (≥18 years) with an implanted ICD for either primary or secondary prevention of sudden cardiac death.
* At least 3 months have passed since ICD implantation.
* Sufficient cognitive ability and fluency in Dutch to provide informed consent and actively participate in the interview.
* Willing and able to participate in a one-time, individual in-depth interview of 30 to 60 minutes.
Exclusion Criteria:
* Current active severe psychiatric disorder or cognitive impairment that would interfere with meaningful participation as based on the medical history..
* Inability to provide informed consent due to legal, cognitive, or communicative limitations.
* Medical instability or terminal illness that, in the opinion of the treating physician or research team, precludes participation.
* Participation in another interventional trial that may influence psychological or behavioral outcomes relevant to this study.
* Participation in the QoL-ICD II trial with longitudinal QoL assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07258602
Study Brief:
Protocol Section:
NCT07258602