PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

  • STATUS
    Recruiting
  • End date
    May 8, 2024
  • participants needed
    970
  • sponsor
    Endotronix, Inc.
Updated on 8 May 2021

Summary

This is a prospective, randomized, controlled, single blind, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients

Details
Condition Heart Failure NYHA Class III
Treatment Cordella™ Pulmonary Artery Sensor System
Clinical Study IdentifierNCT04089059
SponsorEndotronix, Inc.
Last Modified on8 May 2021

Eligibility

Yes No Not Sure

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, 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
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 angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (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 congenital heart disease 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 Cordella PA 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
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