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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT02026635
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Admission for worsening of HF
* Discharged to home
* Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
* Enrolled in Carelink® system and able to transmit data
* Able to participate for at least 3 months
Exclusion Criteria:
* Post heart transplant or actively listed
* End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
* Stage IV or V chronic renal dysfunction (GFR \<25 mol/min per 1.73 M2)
* Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
* Severe pulmonary hypertension not due to left-sided HF
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02026635
Study Brief:
Protocol Section:
NCT02026635