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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT01594112
Eligibility Criteria:
Inclusion Criteria:
* Subject implanted with a single, dual, or triple chambers ICD within the last 3 months
* Home Monitoring® activated and functional since hospital discharge
* Patient willing and able to comply with the protocol and who has provided written informed consent about Home Monitoring®,
* Patient whose medical situation is stable
Exclusion Criteria:
* ICD replacements
* New York Heart Association Function Class IV patients
* Pregnant women or women who plan to become pregnant during the trial
* Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl), liver failure, etc.
* Age \< 18 years
* Patient unable to handle the Biotronik's transmitter correctly
* Change of residence expected during the study
* Insufficient global system for mobile communication (GSM) coverage at patient's home
* Participation in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01594112
Study Brief:
Protocol Section:
NCT01594112