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Status:

ACTIVE_NOT_RECRUITING

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

Lead Sponsor:

Endotronix, Inc.

Conditions:

Heart Failure NYHA Class III

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared t...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Subject has given written informed consent
  • 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, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, 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
  • Exclusion Criteria
  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (\< 3 month prior to Screening Visit)
  • Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
  • Unrepaired severe valvular disease
  • Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart valve(s)
  • Subjects with known coagulation disorders
  • 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
  • Known history of life threatening allergy to contrast dye
  • Subjects whereby RHC is contraindicated
  • Subjects with an active infection at the Sensor Implant Visit
  • Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min or who are on chronic renal dialysis
  • Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
  • Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months
  • Subjects who are pregnant or breastfeeding
  • 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
  • Severe illness, other than heart disease, which would limit survival to \<1 year
  • Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  • Subjects enrolled in another investigational trial with an active treatment arm
  • Subject who is in custody by order of an authority or a court of law

Exclusion

    Key Trial Info

    Start Date :

    January 10 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2028

    Estimated Enrollment :

    738 Patients enrolled

    Trial Details

    Trial ID

    NCT04089059

    Start Date

    January 10 2020

    End Date

    April 1 2028

    Last Update

    March 3 2025

    Active Locations (74)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 19 (74 locations)

    1

    Ascension St Vincent's

    Birmingham, Alabama, United States, 35235

    2

    Huntsville Hospital

    Huntsville, Alabama, United States, 35801

    3

    Phoenix Cardiovascular Research Group/Insight

    Phoenix, Arizona, United States, 85018

    4

    Loma Linda University

    Loma Linda, California, United States, 92354