PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

Running, not enrolling · Not applicable

Conditions studied: Heart Failure NYHA Class III

In brief

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 to a Performance Goal (PG).

Key facts

Study ID: NCT04089059
Run by: Endotronix, Inc.
People needed: 738
Starts: 2020-01-10
Expected to finish: 2028-04-01
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Huntsville Hospital — Huntsville, Alabama, United States
Phoenix Cardiovascular Research Group/Insight — Phoenix, Arizona, United States
Loma Linda University — Loma Linda, California, United States
Eisenhower Medical Center — Rancho Mirage, California, United States
UCSD — San Diego, California, United States
Kaiser San Francisco — San Francisco, California, United States
UCSF Medical Center — San Francisco, California, United States
Kaiser Santa Clara — Santa Clara, California, United States
South Denver Cardiology — Littleton, Colorado, United States
Hartford Hospital — Hartford, Connecticut, United States
Baptist Health South Florida — Miami, Florida, United States
Ascension Sacred Heart — Pensacola, Florida, United States
USF Health — Tampa, Florida, United States
Cleveland Clinic — Weston, Florida, United States
Piedmont Athens — Athens, Georgia, United States
Queens Medical Center — Honolulu, Hawaii, United States
Northwestern — Chicago, Illinois, United States
U of Chicago — Chicago, Illinois, United States
Heart Centers of Illinois — Palos Park, Illinois, United States
OSF Healthcare — Peoria, Illinois, United States
Ascension St Vincent's — Indianapolis, Indiana, United States
University of Iowa Medical Center — Iowa City, Iowa, United States
University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States
University Of Louisville — Louisville, Kentucky, United States
Ascension St Vincent's — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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