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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT02506166
Eligibility Criteria:
Inclusion Criteria:
Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death
Exclusion Criteria:
* Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment
* Patients with previously implanted ICD/CRT-D device indicated for device replacement
* Uncontrolled hypertension
* Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation
* Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant
* Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant
* Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant
* Severe pulmonary diseases
* Rejection of participation in the study
* Pregnancy
* Age of 80 years and higher in time of ICD/CRT-D implant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
18 Years
Study:
NCT02506166
Study Brief:
Protocol Section:
NCT02506166