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 (PROACTIVE-HF Trial)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Acute Decompensated Heart Failure
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who are at least 18 years old and will provide written informed consent
    2. Diagnosis and treatment of Heart Failure (HF)
    3. On stable, optimally titrated medical therapy for at least 30 days
    4. Heart Failure related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month
    5. Participants should be on diuretic therapy
    6. Participants 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
    7. Participants with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader’s audio/visual cues and operate the myCordella™ Patient Reader
    8. Has sufficient Cellular and/ or Wi- Fi Internet coverage at home
    9. Agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow ups

You may not be eligible for this study if the following are true:

    1. Intolerance to all neuro-hormonal antagonists due to hypotension or renal dysfunction
    2. American College of Cardiology/American Heart Association (ACC/AHA) Stage D refractory Heart failure (HF)
    3. Participants with history of recurrent pulmonary embolism
    4. Participants who have had a major cardiovascular (CV) event
    5. Unrepaired severe valvular disease
    6. Participants with congenital heart disease or mechanical/tissue right heart valve(s)
    7. With known coagulation disorders
    8. 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
    9. Known history of life threatening allergy to contrast dye
    10. Subjects whereby Right Heart Catheter (RHC) is contraindicated
    11. With an active infection at the Cordella PA Sensor Implant Visit
    12. With a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
    13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior
    14. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months
    15. Pregnant or breastfeeding
    16. Unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
    17. Severe illness, other than heart disease, which would limit survival to less than 1 year
    18. Whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
    19. Enrolled in another investigational trial



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