SIRONA Trial Heart Failure NYHA Class III

Korábbi kezelés

• Any major surgery within 30 days of the Sensor Implant Visit.
• Subjects with large metal implants/prostheses or any other materials in the thoracic cavity that may interfere with the Cordella™ Pulmonary Artery Sensor System performance

Más betegség

• Subjects with primary pulmonary hypertension.
• Subjects with an active infection at the Sensor Implant Visit
• Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
• Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of the Screening Visit
• Subjects with a Cardiac Resynchronization Device (CRT), Internal Cardiac Defibrillator (ICD) or pacemaker (if implanted less than 6 months or has more than a single lead), or Left Ventricular Assist Device (LVAD)
• Subjects likely to undergo lung and/ or heart transplantation within 24 months of the Screening Visit.
• Subjects with congenital heart disease or mechanical/tissue right heart valve(s)
• Subjects with known coagulation disorders
• Known history of life threatening allergy to contrast dye.
• Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
• Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
• Severe illness, other than heart disease, which would limit survival to \<1 year
• Subjects who have had intractable arrhythmias within 2 month of the Screening Visit

Laborértékek

• Subjects with a Glomerular Filtration Rate (GFR) \<30 ml/min or who are on chronic renal dialysis
• Specific liver enzymes \[Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT) \>3 times the upper limit of normal
• Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one month post implant

Egyéb

• Subjects whereby RHC or computed tomography pulmonary angiography (CTPA) is contraindicated
• Subjects enrolled in another investigational trial.
• Subjects with an indwelling inferior vena cava (IVC) filter
• Subjects who are pregnant or breastfeeding
• Subjects with patent foramen ovale (PFO)

• Subject has given written informed consent
• Male or female, at least 18 years of age
• Diagnosis of HF ≥ 3 months with either preserved or reduced left ventricular ejection fraction (LVEF)
• Diagnosis of NYHA Class III HF at the time of Screening with at least 1 HF-related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit within the last year
• Subjects must be receiving appropriate medical management of HF for 3 months prior to Screening and clinically stable for at least 1 month prior to study entry
• Subjects with a Body Mass Index (BMI) \< 35 kg/mL2 and chest circumference \< 1050 mm
• Subjects with right pulmonary artery branch diameter sized between 14 mm and 20 mm (target Sensor implant site) over a length of at least 30mm
• Subjects with distance between target implant site (right PA branch) and ventral thoracic skin surface of \< 12cm
• Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 600g) against the ventral thoracic surface for up to 2 minutes per day while in a seated. position, as well as dock and undock the myCordella™ Patient Reader
• Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader.
• Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
• Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up
• Subject compliance as defined by data collection and transmissions at least 5 days a week (does not have to be consecutive days) using the myCordella™ Hub \& Peripherals for at least 1 week during the screening period