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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT01626404
Eligibility Criteria:
Inclusion Criteria:
* CRT and or ICD device in place.
* NYHA class III - IV heart failure
* EF \</= 40%
* Patient is an out-patient
* Patient is on optimal medical management as tolerated and as defined by primary care physician.
* Patient has signed an informed consent for data collection.
Exclusion Criteria:
* Age \<18 years or \>80 years
* CRT device that has been implanted \< 3 months prior to enrollment
* Coronary revascularization within 3 months prior to enrollment
* Patient only has ICD but has CRT planned
* Non-cardiac disease resulting in life expectancy \< 2 yrs
* Patient is hospitalized or will be hospitalized at this time
* Known diagnosis of dementia
* Patient is currently on dialysis
* Oxygen dependent lung disease
* Previously or currently treated with LVAD or heart transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01626404
Study Brief:
Protocol Section:
NCT01626404