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A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients
The primary objective of this trial is to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III heart failure patients.
- Male or female, at least 18 years of age
- Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
- Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
- HF-related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening /Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at time of Screening/ Enrollment defined as:
- Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
- Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL .
- Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
- Subjects should be on diuretic therapy
- Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) 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