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Tiny lung sensor could keep heart failure patients out of the hospital

NCT ID NCT04089059

Disease control Sponsor: Endotronix, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tested a small sensor placed in the lung artery to help doctors monitor heart failure patients remotely. 738 people with advanced (NYHA Class III) heart failure took part. The goal was to see if using the sensor could reduce hospitalizations and deaths compared to a target goal. The sensor sends pressure readings so doctors can adjust treatment early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

738 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Subject has given written informed consent 2. Male or female, at least 18 years of age 3. Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening 4. 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. 5. 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: 1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL. 2. 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 6. Subjects should be on diuretic therapy 7. 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 8. 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 9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home 10. 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 1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction 2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes) 3. 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) 4. Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit 5. Unrepaired severe valvular disease 6. 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) 7. Subjects with known coagulation disorders 8. 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 9. Known history of life threatening allergy to contrast dye 10. Subjects whereby RHC is contraindicated 11. Subjects with an active infection at the Sensor Implant Visit 12. Subjects 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 to screening visit 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. Subjects who are pregnant or breastfeeding 16. 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 17. Severe illness, other than heart disease, which would limit survival to \<1 year 18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study 19. Subjects enrolled in another investigational trial with an active treatment arm 20. Subject who is in custody by order of an authority or a court of law

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart failure moderate heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure nyha class III

Contacts and locations

Locations

  • Ascension Sacred Heart

    Pensacola, Florida, 32504, United States

  • Ascension St Vincent's

    Birmingham, Alabama, 35235, United States

  • Ascension St Vincent's

    Indianapolis, Indiana, 46260, United States

  • Austin Heart

    Austin, Texas, 78756, United States

  • Baptist Health South Florida

    Miami, Florida, 33176, United States

  • Baylor - Round Rock

    Round Rock, Texas, 78655, United States

  • Baylor - Temple

    Temple, Texas, 76508, United States

  • Baylor/Texas Heart

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital (Mass General Brigham)

    Boston, Massachusetts, 02215, United States

  • Cardiovascular Center OLV Aalst

    Aalst, Belgium

  • Centra Care Heart Center

    Saint Cloud, Minnesota, 56303, United States

  • Cleveland Clinic

    Weston, Florida, 33331, United States

  • Craig Cardiovascular Center

    Gonzales, Texas, 78155, United States

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Heart Centers of Illinois

    Palos Park, Illinois, 60464, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Huntsville Hospital

    Huntsville, Alabama, 35801, United States

  • Kaiser San Francisco

    San Francisco, California, 94118, United States

  • Kaiser Santa Clara

    Santa Clara, California, 95051, United States

  • Loma Linda University

    Loma Linda, California, 92354, United States

  • Medstar

    Baltimore, Maryland, 21239, United States

  • Methodist Healthcare System

    San Antonio, Texas, 78229, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • NYU Langone Health

    New York, New York, 11794, United States

  • New York Presbyterian Queens

    Queens, New York, 11355, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • OSF Healthcare

    Peoria, Illinois, 61107, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oregon Health Science Portland

    Portland, Oregon, 97239, United States

  • PRISMA Health- Upstate

    Greenville, South Carolina, 29605, United States

  • PRISMA Midlands - Palmetto

    Columbia, South Carolina, 29203, United States

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Penn State Health

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Cardiovascular Research Group/Insight

    Phoenix, Arizona, 85018, United States

  • Piedmont Athens

    Athens, Georgia, 30600, United States

  • Providence Health Care

    Spokane, Washington, 99204, United States

  • Queens Medical Center

    Honolulu, Hawaii, 96813, United States

  • Sanford

    Sioux Falls, South Dakota, 57105, United States

  • Sentara Healthcare

    Norfolk, Virginia, 22191, United States

  • South Denver Cardiology

    Littleton, Colorado, 80120, United States

  • St. Lukes/ Mid-American Heart Institute

    Kansas City, Missouri, 64111, United States

  • Stony Brook University Med Center

    Stony Brook, New York, 11794, United States

  • Tennova Healthcare (Turkey Creek Medical Center)

    Knoxville, Tennessee, 37934, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • Thomas Jefferson

    Philadelphia, Pennsylvania, 19107, United States

  • Thomas Jefferson Abington

    Abington, Pennsylvania, 19001, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • U of Chicago

    Chicago, Illinois, 60637, United States

  • UCSD

    San Diego, California, 92037, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • USF Health

    Tampa, Florida, 33609, United States

  • University Hospital Galway

    Galway, Ireland

  • University Of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Medical Center

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Texas/Hermann Memorial

    Houston, Texas, 77030, United States

  • University of Vermont

    Burlington, Vermont, 05401, United States

  • University of Washington

    Seattle, Washington, 98196, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Valley Health System/Winchester Medical Center

    Winchester, Virginia, 22601, United States

  • Vanderbilt

    Nashville, Tennessee, 37232, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • ZNA Middlheim

    Antwerp, Belgium

  • Ziekenhuis- Oost Limburg

    Genk, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.