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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT00559559
Eligibility Criteria:
Inclusion Criteria:
* Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;
* Patient is willing and able to independently comprehend and complete the study-related questionnaires;
* Patient has signed the study specific informed consent form.
Exclusion Criteria:
* have already had a Patient Notifier™ alert since implant;
* had a prior device implant (PM or ICD);
* have not been discharged from the hospital since device implant;
* have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
* cannot commit to the follow-up schedule;
* have a life expectancy of less than 1 year;
* are on a waiting list for a heart transplant;
* are less than 18 years old;
* are pregnant;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00559559
Study Brief:
Protocol Section:
NCT00559559