Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction

Exclusion Criteria

• •1. Hospitalization for HF within 7 days prior to screening.
• •2. Participation in an interventional trial (using investigational drug or device) of a non-observational registry study within 14 days prior to screening.
• •3. History of blood or bone marrow donation within 4 weeks prior to screening, or planned donation during the study.
• •4. Implantation of pulmonary artery pressure monitor or pacemaker within 4 weeks prior to screening, or planned implantation during the study.
• •5. Hospitalization within 30 days prior to screening for: acute ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina, percutaneous coronary intervention (PCI), or cardiac surgery.
• •6. Cardiac resynchronization therapy (CRT) within 90 days prior to screening.
• •7. Planned revascularization (PCI or CABG), major cardiac surgery (including coronary artery bypass grafting, valve replacement, ventricular assist device implantation, heart transplantation, other surgery requiring thoracotomy), transcatheter aortic valve replacement (TAVR), or CRT implantation within 90 days after screening.
• •8. History of femoral or jugular vein surgery.
• •9. Life expectancy \<1 year at screening.
• •10. Estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73 m² at screening (calculated using the modified MDRD formula).
• •11. BNP \<150 pg/ml and NT-proBNP \<300 pg/ml at screening.
• •12. Serum potassium \>5.5 mmol/L at screening.
• •13. Physical examination showing volume depletion at screening or randomization.
• •14. Mean supine systolic blood pressure \<100 mmHg at screening or randomization.
• •15. Uncontrolled hypertension, defined as mean supine systolic blood pressure ≥160 mmHg (average of three measurements) at screening.
• •16. Documented stable-state LVEF \<40% within the past 24 months.
• •17. Current active malignancy (excluding non-melanoma skin cancer).
• •18. HF due to specific cardiomyopathies, including: restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular stenosis, hypertrophic obstructive cardiomyopathy (HOCM).
• •19. Chronic obstructive pulmonary disease (COPD) judged as the primary cause of dyspnea.
• •20. Myocardial ischemia judged as the primary cause of dyspnea.
• •21. Isolated right heart failure due to pulmonary disease.
• •22. Complex congenital heart disease.
• •23. History of allergic reaction to guideline-directed HF medications.
• •24. Pregnant/lactating women. Women of childbearing potential (WOCBP) defined as post-menarche and not permanently sterilized (hysterectomy/bilateral tubal ligation) or postmenopausal (natural amenorrhea ≥12 months without other medical cause). Sexually active WOCBP must agree to use medically accepted contraception during the study, including: \|surgical sterilization, progestin contraceptives (oral/implant), barrier methods (condom/diaphragm) with spermicide, intrauterine device (IUD). Urine pregnancy test required at each visit; negative result required for continued participation.