Trial Purpose and Description
To determine if a significant decrease in the rate of heart failure (HF) rehospitalizations
occurs during the entire follow-up period when ReDS guided treatment is used as an adjunct to standard of care (SOC)
Ages: 21 years and older
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.Patient's residence has adequate cellular data coverage
4.Diagnosis of HF, with preserved or reduced LVEF, was made at least 90 days prior to enrollment.
5.Patients with LVEF <40% must have been treated at least 90 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).
6.Patient is hospitalized for ADHF requiring treatment with IV diuretics or vasoactive drugs.
7.BNP ≥ 500 pg/ml (NT pro BNP > 1500 pg/ml) at enrollment (within 24h) and/or ≥750 pg/ml any time during the hospital stay (NT-pro BNP >2200 pg/ml).
Main Exclusion Criteria:
1.HF patient with Class D objective assessment (i.e. Objective evidence of severe cardiovascular disease. Severe limitations. Experiences symptoms even while at rest)
2.At discharge patient is unable to ambulate to bathroom and back to his bed (minimal assistance allowed).
3.Patient has had a cardiac transplantation or VAD implantation.
4.CRT implantation within 90 days prior to screening or planned implantation during study duration.
5.History of pulmonary embolism.
6.Diagnosis of Severe Pulmonary Hypertension.
7.Experienced a major cardiac event (e.g., myocardial infarction, stroke, surgery) within two months of screening visit.
8.Chronic renal failure with CrCl<25mL/min, as calculated by the Cockcroft-Gault formula.
9.Chronic home IV therapy or cardiac inotropes or diuretics
10.Physical deformity in the thorax area or lesion that may prevent proper vest application or adjustment (Severe scoliosis/ sensitive sternotomy lesion etc.).
11.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).
12.Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator's assessment.
13.Patient's habitus out of range due to one or more of the following:
◦Height less than 155cm or higher than 190cm (5.1; 6.2 feet respectively).
◦BMI of less than 22 or more than 36.
14.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.
15.COPD with home use of O2 and/ or oral steroids.
Sensible Medical Innovations
Dates: 03/10/2016 - 09/30/2017
Last Updated: 03/11/2016
Study HIC#: 1510016594