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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT06024369
Eligibility Criteria:
Inclusion Criteria: Heart failure (HF) patients regardless of ejection fraction, HFpEF (heart failure preserved ejection fraction) or HFrEF (heart failure reserved ejection fraction) with one or more of the following:
* New York Heart Association (NYHA) Class III HF
* NYHA Class IV HF OR
* NYHA Class II HF with one/. or more of the following:
* Chronic Kidney Disease (eGFR\<60 within the past 6 months)
* HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200 pg/ml\* (N-terminal pro b-type natriuretic peptide) for patients not in atrial fibrillation (AF) or \> 600 pg/ml\* for patients in AF on screening ECG+
* NT-proBNP \> 300 pg/ml\* for patients not in AF or \> 900 pg/ml\* for patients in AF on the screening visit ECG+
* Chronic obstructive pulmonary disease (COPD)
Exclusion Criteria:
* Under 18 years of age
* Patients with severe COPD (GOLD stage III or IV)
* Limited mobility preventing application of device or no caregiver to assist
* Cognitive impairments that would limit the application and proper use of the device
* Skin allergies or skin sensitivities to silicone-based adhesives
* Pregnancy (method of assessment at the discretion of the PI)
* Not willing to shave chest hair if needed to apply device
* Patients on chronic IV (intravenous) ionotropic therapy - (Milrinone, Dobutamine, and Dopamine)
* Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
* No cellular coverage (Patient's Home)\*\*
* Skin breakdown on the left chest or breast area
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06024369
Study Brief:
Protocol Section:
NCT06024369