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 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT04344704
Eligibility Criteria:
Inclusion Criteria:
* Patients with an indication of a single chamber ICD due to high risk of sudden death.
* Patients with and without a prior history of AF.
* Patients with indication for primary and secondary prevention.
* Device optimized for the discrimination of supraventricular events.
* DX device implant with single floating cable.
* Activation of "Home Monitoring" function.
* Over 18 years.
* Signature of informed consent
Exclusion Criteria:
* Indication for permanent atrial pacing according to current pacing guidelines.
* Congestive heart failure grade IV.
* Candidates for Cardiac Resynchronization Therapy.
* Patients with a previous device.
* Permanent Atrial Fibrillation.
* Life expectancy less than 12 months.
* Pregnant or lactating women.
* Patients who are unable to understand the nature of the study.
* Subjects with irreversible brain damage caused by pre-existing brain disease.
* Heart transplant 6 months prior to recruitment or expected in the next 3 months.
* Cardiac surgery 3 months prior to recruitment or planned for the next 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04344704
Study Brief:
Protocol Section:
NCT04344704