Clinical trial Recruiting at 44 sites Interventional Ages 18 and up

Evaluating the Cordella Pulmonary Artery Sensor System for Heart Failure

Official title: A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients

Run by Endotronix, Inc. · NCT05934487 · Data updated 2026-11-12

This study is testing a new device that helps people with heart failure keep track of their heart health to see if it can improve their management of the condition.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1750 (estimated)
SponsorEndotronix, Inc.
Industry-sponsored
Locations48 sites (Phoenix, Arizona and 47 other locations)
StatusRecruiting
StartedNovember 29, 2023
Main results expectedSeptember 2028
Study endsSeptember 2033
Registry record updatedJune 29, 2026
Trial IDNCT05934487 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older diagnosed with NYHA Class II or III heart failure who have been on appropriate medical therapy for at least 30 days.

Probably not a fit

Patients with heart failure who do not meet the NYHA Class II or III criteria or those who are not receiving standard medical therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, multi-center, open label, randomized control evaluation of the Cordella™ Pulmonary Artery Sensor System in patients with NYHA Class II and III heart failure. It includes five arms, with specific cohorts for NYHA Class II and III patients, assessing the safety and efficacy of the device while providing daily access to pulmonary artery pressure data. The study aims to determine the effectiveness of a clinician-directed patient self-management strategy in the NYHA III cohort. Participants will be monitored for their response to the intervention over a defined period.

Why it matters

Potential benefit: If successful, this study could improve management and outcomes for patients with heart failure by providing real-time monitoring and personalized treatment strategies.

How similar studies have gone: Other studies evaluating similar monitoring technologies in heart failure have shown promising results, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • St. Joseph's Hospital and Medical Center
    Phoenix, Arizona, United States
    Recruiting
  • USC
    Los Angeles, California, United States
    Recruiting
  • UCSF Medical Center
    San Francisco, California, United States
    Recruiting
  • Baptist Health South Florida
    Miami, Florida, United States
    Recruiting
  • Ascension Sacred Heart
    Pensacola, Florida, United States
    Recruiting
  • Piedmont
    Atlanta, Georgia, United States
    Recruiting
Show 42 more locations
  • Advocate Health System
    Downers Grove, Illinois, United States
    Recruiting
  • Heart Care Centers of Illinois (HCCI)
    Palos Park, Illinois, United States
    Recruiting
  • Ascension St. Vincent's
    Indianapolis, Indiana, United States
    Recruiting
  • University of Kansas Medical Center (KUMC)
    Kansas City, Kansas, United States
    Recruiting
  • MedStar
    Baltimore, Maryland, United States
    Recruiting
  • Tufts Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Ascension Providence Hospital Cardiology - Heart Cardiology
    Howell, Michigan, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • Centra Care Heart Center
    Saint Cloud, Minnesota, United States
    Recruiting
  • St. Lukes/ Mid-American Heart Institute
    Kansas City, Missouri, United States
    Recruiting
  • Mount Sinai West
    New York, New York, United States
    Recruiting
  • Mount Sinai
    New York, New York, United States
    Recruiting
  • Lenox Hill/ Northwell Health
    New York, New York, United States
    Recruiting
  • Stony Brook University Med Center
    Stony Brook, New York, United States
    Recruiting
  • UNC Medical Center
    Durham, North Carolina, United States
    Recruiting
  • Duke University
    Durham, North Carolina, United States
    Recruiting
  • The Christ Hospital- Cincinnati
    Cincinnati, Ohio, United States
    Recruiting
  • University of Cincinnati
    Cincinnati, Ohio, United States
    Recruiting
  • University Hospital (Cleveland)
    Cleveland, Ohio, United States
    Recruiting
  • Providence St. Vincent's - Portland
    Portland, Oregon, United States
    Recruiting
  • Oregon Health Science Portland
    Portland, Oregon, United States
    Recruiting
  • Penn State Health
    Hershey, Pennsylvania, United States
    Recruiting
  • Upmc
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Medical University of South Carolina (MUSC)
    Charleston, South Carolina, United States
    Recruiting
  • PRISMA Health- Upstate
    Greenville, South Carolina, United States
    Recruiting
  • Sanford
    Sioux Falls, South Dakota, United States
    Recruiting
  • Vanderbilt
    Nashville, Tennessee, United States
    Recruiting
  • Austin Heart
    Austin, Texas, United States
    Recruiting
  • Medical City Healthcare Dallas
    Dallas, Texas, United States
    Recruiting
  • Baylor Scott & White -Dallas
    Dallas, Texas, United States
    Recruiting
  • Baylor/Texas Heart
    Houston, Texas, United States
    Recruiting
  • Methodist San Antonio
    San Antonio, Texas, United States
    Recruiting
  • Baylor - Temple
    Temple, Texas, United States
    Recruiting
  • University of Vermont
    Burlington, Vermont, United States
    Recruiting
  • Providence Everett
    Everett, Washington, United States
    Recruiting
  • West Virginia University
    Morgantown, West Virginia, United States
    Recruiting
  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting
  • Advocate Aurora St. Luke's
    Milwaukee, Wisconsin, United States
    Recruiting
  • Boston Medical Center Corporation
    Boston, Massachusetts, United States
    Not yet recruiting
  • AZORG Aalst
    Aalst, Belgium
    Active not recruiting
  • UZ Brussel
    Brussels, Belgium
    Active not recruiting
  • University Hospital Galway
    Galway, Ireland
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • SmartSignalHF remote monitoring for people with implanted ICD or CRT‑D and heart failure

    This tests whether SmartSignalHF remote monitoring for people with implanted ICD or CRT‑D and chronic heart failure can reduce deaths and heart failure hospital visits over 12 months compared with standard remote monitoring.

    Recruiting Implicity · Paris · NCT07247032

  • Barostim therapy to help heart failure patients stay well

    This study tests whether Barostim System-based baroreflex activation can reduce death and serious heart failure events in adults with moderate heart failure already on guideline-directed therapy.

    Recruiting at 20 sites CVRx, Inc. · Mobile, Alabama and 22 other locations · NCT07232030

  • Improving well-being and health in heart failure patients

    This study is testing a new phone-based program that combines positive psychology and motivational support to see if it can help heart failure patients improve their health and well-being over six months.

    Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT04829617

  • Baduanjin exercise program for chronic heart failure patients

    This study tests whether a traditional Chinese exercise program can help people with chronic heart failure feel better and improve their overall health.

    Recruiting Guangdong Provincial Hospital of Traditional Chinese Medicine · Guangzhou, Guangdong · NCT03180320

  • Yoga-based cardiac rehabilitation for heart failure with reduced ejection fraction

    This trial tests whether a yoga-based rehabilitation program can help people with heart failure and reduced ejection fraction compared with an educational program.

    Recruiting at 12 sites Centre for Chronic Disease Control, India · Dharwad, Karnataka and 15 other locations · NCT07817589

  • Using Apple Watch data to predict heart failure outcomes

    This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

    Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.