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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1750 (estimated) |
| Sponsor | Endotronix, Inc. Industry-sponsored |
| Locations | 48 sites (Phoenix, Arizona and 47 other locations) |
| Status | Recruiting |
| Started | November 29, 2023 |
| Main results expected | September 2028 |
| Study ends | September 2033 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT05934487 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
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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
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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
- Study coordinator: Sarah Walton
- Email: sarah_walton@edwards.com
- Phone: (630) 473-3200
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
-
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.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.