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Clinical Trials in Ireland / NCT05934487
Recruiting

PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

NCT05934487 · tracked via the Priya Life Science Ireland tracker
Sponsor
Endotronix, Inc.
Phase
N/A
Started
2023-11-29
Last updated
2026-06-29

Condition(s) studied

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure

Investigational drug(s) / intervention(s)

Cordella™ Pulmonary Artery Sensor System

Cordella™ Pulmonary Artery Sensor System: The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management, with the goal of reducing heart failure hospitalizations. The system comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation. Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Tablet Cordella Data Analysis Platform (CDAP)

Study summary

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).

The study contains of 5 arms:

NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.

* Treatment Arm (Group 1)
* Active Control Arm (Group 2)
* Crossover Arm (Group 3)

NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
St. Joseph's Hospital and Medical Center Phoenix Arizona Recruiting
USC Los Angeles California Recruiting
UCSF Medical Center San Francisco California Recruiting
Baptist Health South Florida Miami Florida Recruiting
Ascension Sacred Heart Pensacola Florida Recruiting
Piedmont Atlanta Georgia Recruiting
Advocate Health System Downers Grove Illinois Recruiting
Heart Care Centers of Illinois (HCCI) Palos Park Illinois Recruiting
Ascension St. Vincent's Indianapolis Indiana Recruiting
University of Kansas Medical Center (KUMC) Kansas City Kansas Recruiting
MedStar Baltimore Maryland Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
Boston Medical Center Corporation Boston Massachusetts Not Yet Recruiting
Ascension Providence Hospital Cardiology - Heart Cardiology Howell Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Centra Care Heart Center Saint Cloud Minnesota Recruiting
St. Lukes/ Mid-American Heart Institute Kansas City Missouri Recruiting
Mount Sinai West New York New York Recruiting
Mount Sinai New York New York Recruiting
Lenox Hill/ Northwell Health New York New York Recruiting
Stony Brook University Med Center Stony Brook New York Recruiting
UNC Medical Center Durham North Carolina Recruiting
Duke University Durham North Carolina Recruiting
The Christ Hospital- Cincinnati Cincinnati Ohio Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
University Hospital (Cleveland) Cleveland Ohio Recruiting
Providence St. Vincent's - Portland Portland Oregon Recruiting
Oregon Health Science Portland Portland Oregon Recruiting
Penn State Health Hershey Pennsylvania Recruiting
UPMC Pittsburgh Pennsylvania Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
PRISMA Health- Upstate Greenville South Carolina Recruiting
Sanford Sioux Falls South Dakota Recruiting
Vanderbilt Nashville Tennessee Recruiting
Austin Heart Austin Texas Recruiting
Medical City Healthcare Dallas Dallas Texas Recruiting
Baylor Scott & White -Dallas Dallas Texas Recruiting
Baylor/Texas Heart Houston Texas Recruiting
Methodist San Antonio San Antonio Texas Recruiting
Baylor - Temple Temple Texas Recruiting

+ 8 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05934487 on ClinicalTrials.gov ↗ ← All trials in Ireland