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

Launched by ENDOTRONIX, INC. · Jun 28, 2023

Keywords

ClinConnect Summary

The PROACTIVE-HF-2 trial is studying a new device called the Cordella™ Pulmonary Artery Sensor System to see how safe and effective it is for patients with heart failure, specifically those classified as NYHA Class II and III. This trial has two main groups: one group will receive the sensor along with standard care, while the other group will receive standard care only. The trial aims to help patients better manage their heart failure and potentially improve their health outcomes.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with heart failure for at least three months. They should also be receiving appropriate heart failure treatment as recommended by health guidelines. Participants can expect regular check-ups and monitoring throughout the study to ensure their safety. This trial is currently recruiting participants, and it’s open to individuals of all genders within the specified age range. If you're interested in learning more about participating, it's a good idea to discuss it with your healthcare provider.

Gender

ALL

Eligibility 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