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:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT06078267
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-IV
* NYHA Class II HF with one or more of the following:
* Chronic Kidney Disease (eGFR\<60 within the past 6 months) (Estimated Glomerular Filtration Rate)
* HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP (N-terminal pro b-type natriuretic peptide) \> 200 pg/ml for patients not in atrial fibrillation (AF) or \> 600 pg/m for patients in AF on screening ECG (electrocardiogram)
* 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
* Cognitive impairments that would limit the application and proper use of the device
* Skin allergies or skin sensitivities to silicone-based adhesives
* Pregnancy
* Skin breakdown on the left chest or breast area
* Not willing to shave chest hair if needed to apply device
* Patients on chronic ionotropic therapy
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06078267
Study Brief:
Protocol Section:
NCT06078267