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Wireless Lung-Artery sensor could keep heart failure patients out of hospital

NCT ID NCT05934487

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Updated 2 times

Summary

This trial tests a small sensor placed in the pulmonary artery (the blood vessel from the heart to the lungs) that wirelessly sends daily pressure readings to doctors. The goal is to help people with moderate heart failure (NYHA Class II or III) manage their condition at home and avoid hospital stays. About 1,750 participants will be randomly assigned to get the sensor or standard care, and researchers will track heart failure events and deaths over up to 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cordella™ Pulmonary Artery Sensor System (implantable device)
What this could lead to
If successful, this device could help heart failure patients manage their condition at home, reducing hospital visits and improving quality of life.
What could go wrong
This is an early-stage trial with 1750 participants; the device requires a procedure to implant, which carries risks like infection or sensor failure. It may not significantly reduce hospitalizations.

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

About 1,750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Sep 2033

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 LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening 4\. Subjects should be receiving appropriate medical therapy for heart failure according to current AHA/ACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior to the Screening/Enrollment visit. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waived if a subject is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented. 1. HFrEF (EF \< 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to Screening/Enrollment 2. HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject's tolerance of SGLT2i as determined by the study investigator for at least 30 days prior to Screening/Enrollment 5. NYHA II Cohort- HF related hospitalization within 6 months (last hospitalization should be 30 days before Screening /Enrollment) 5. NYHA III Cohort -HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening/Enrollment) 6\. Subjects should be on diuretic therapy (≥40 mg\] furosemide or equivalent) for ≥ 1 month at time of Screening 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. ACC/AHA Stage D refractory HF (including a known history of \>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure)) 2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (\< 3 month prior to Screening Visit) 3. Subjects with a resting systolic blood pressure \<90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2) 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 Cordella Sensor Implant Visit 12. Subjects with a GFR \<20 ml/min or who are on chronic renal dialysis 13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit 14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 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 \<2 years 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 mild heart failure moderate heart failure

As listed by the trial registrant

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

Heart failure Heart failure nyha class II Heart failure nyha class III

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZORG Aalst

    ACTIVE_NOT_RECRUITING

    Aalst, 9300, Belgium

  • Advocate Aurora St. Luke's

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Advocate Health System

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Ascension Providence Hospital Cardiology - Heart Cardiology

    RECRUITING

    Howell, Michigan, 48843, United States

  • Ascension Sacred Heart

    RECRUITING

    Pensacola, Florida, 32504, United States

  • Ascension St. Vincent's

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Austin Heart

    RECRUITING

    Austin, Texas, 78756, United States

  • Baptist Health South Florida

    RECRUITING

    Miami, Florida, 33176, United States

  • Baylor - Temple

    RECRUITING

    Temple, Texas, 76508, United States

  • Baylor Scott & White -Dallas

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baylor/Texas Heart

    RECRUITING

    Houston, Texas, 77030, United States

  • Boston Medical Center Corporation

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02118, United States

  • Centra Care Heart Center

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Heart Care Centers of Illinois (HCCI)

    RECRUITING

    Palos Park, Illinois, 60464, United States

  • Lenox Hill/ Northwell Health

    RECRUITING

    New York, New York, 10075, United States

  • MedStar

    RECRUITING

    Baltimore, Maryland, 21239, United States

  • Medical City Healthcare Dallas

    RECRUITING

    Dallas, Texas, 75240, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Methodist San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

  • Oregon Health Science Portland

    RECRUITING

    Portland, Oregon, 97239, United States

  • PRISMA Health- Upstate

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Penn State Health

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Piedmont

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Providence Everett

    RECRUITING

    Everett, Washington, 98201, United States

  • Providence St. Vincent's - Portland

    RECRUITING

    Portland, Oregon, 97225, United States

  • Sanford

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • St. Joseph's Hospital and Medical Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • St. Lukes/ Mid-American Heart Institute

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Stony Brook University Med Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The Christ Hospital- Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UCSF Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • UNC Medical Center

    RECRUITING

    Durham, North Carolina, 27703, United States

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • UZ Brussel

    ACTIVE_NOT_RECRUITING

    Brussels, Belgium

  • University Hospital (Cleveland)

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Hospital Galway

    ACTIVE_NOT_RECRUITING

    Galway, Ireland

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Kansas Medical Center (KUMC)

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Vermont

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Vanderbilt

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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