Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients (SMILE™)

This is an interventional prevention trial for Heart Failure focused on measuring Heart Failure, Remote Patient Monitoring, Non Invasive Lung Fluid Status Monitor Read More

Main Inclusion Criteria:

1. Patient has signed informed consent and authorization to use and disclose health information.
2. Patient's physical condition enables him to sit up and lay down with minimal assistance.
3. Diagnosis of HF, with preserved or reduced LVEF, was made at least 30 days prior to enrollment.
4. Patients with LVEF <40% must have been treated at least 30 days prior to enrollment with diuretics and beta-blocker (unless intolerant or contra-indicated) and an ACE-inhibitor or ARB (unless intolerant or contra-indicated).
5. Patient is hospitalized for ADHF requiring significant alteration in heart failure treatment (i.e. diuretics or vasoactive drugs) or up to 10 days post-discharge from an ADHF admission.
6. BNP ≥ 350 pg/ml (NT pro BNP > 1400 pg/ml) at enrollment (within 24h) and/or ≥750 pg/ml any time during the hospital stay (NT-pro BNP >3000 pg/ml).

Note that if a patient is enrolled during a clinic visit rather than during a hospitalization, then the BNP from the index admission is referenced.

Main Exclusion Criteria:

1. Patient has had a cardiac transplantation or VAD implantation.
2. CRT implantation within 90 days prior to screening or planned implantation during study duration.
3. Current or past Pulmonary Embolism in the right lung. Notes: (i) Past pulmonary emboli are defined as identified <6 months prior to enrollment. (ii) past or current tiny, microscopic pulmonary emboli do not exclude a patient. (iii) if a ventilation-perfusion (VQ) scan shows that the lungs are clear, then the exclusion criteria is not met.
4. Diagnosis of Severe Pulmonary Hypertension.
5. STEMI and or CABG within 30 days of screening visit. Note: Type 2 MI due to ADHF is not an exclusion.
6. Chronic renal failure with CrCl<25mL/min, as calculated by the Cockcroft-Gault formula.
7. Chronic home IV therapy or cardiac inotropes or diuretics
8. Physical deformity in the thorax area or lesion that may prevent proper vest application or adjustment (Severe scoliosis/ sensitive sternotomy lesion etc.).
9. Illness/ Condition which may be aggravated or cause significant discomfort by the application of the vest (Rib fractures, with or without flail chest, Severe Osteoporosis).
10. Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.

11. Patient's habitus out of range due to one or more of the following:

    • Height less than 155cm or higher than 195cm (5.1; 6.4 feet respectively).
    • BMI of less than 22 or more than 36. In case of BMI between 36-38, if the measured vest ruler is not >=4, the exclusion criteria is met.
12. Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (Dextrocardia, Lung Carcinoma etc.) including pacemaker box on the right side of the chest.
13. Severe COPD, defined as chronic and continuous home use of O2 (O2 dependancy) and/ or oral steroids. Continuous is defined as 24hours a day, every day.
14. Severe disease / conditions with life expectancy <6 months according to investigator's assessment.
15. Patient is enrolled in another interventional study with permission of study manager (observational or registries are not excluded).
16. Patient HF is managed remotely with another monitoring device or program (for example: Pulmonary/ Lt Atrial pressure monitoring, Weight scale, BNP or bioimpedance).
17. Prisoners and ward of the state