this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making
Age ≥18 years and ≤80 years;
Diagnosed with pulmonary hypertension (defined as mPAP >20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;
No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);
Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;
Cardiac index (CI) < 1.5 L/min/m²;
Severe renal insufficiency (creatinine clearance rate (CrCL) < 30 mL/min);
Left ventricular ejection fraction (EF) <30% on echocardiography;
Severe hematological disease or severe bleeding tendency (platelet count <10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);
Parallel
Percutaneous Pulmonary Artery Denervation (PADN)
Device\*\*PADN Procedure Steps:\*\* 1. Non-Selective Pulmonary Artery Angiography 2. PADN Ablation Target Selection 3. Hemodynamic Assessment 4. Establishment of the PADN® RF Catheter Delivery Rail 5. PADN® RF Catheter Delivery 6. Performance of the PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A, B, and C. . Temperature-controlled mode is recommended for radiofrequency ablation, with the ablation temperature set to 50°C and the total ablation time set to 150 seconds. The pulmonary artery radiofrequency ablation generator will automatically start calculating the effective ablation time (ET) once the ablation temperature reaches 45°C. Ablation at each target point is considered effective when the ET reaches at least 120 seconds. 7. Completion of the PADN
Control group (receiving standard medical therapy alone)
DrugControl group (receiving standard medical therapy alone)
Clinical worsening event
defined as the occurrence of any of the following: 1. Worsening heart failure symptoms requiring intravenous therapy (inotropes, diuretics, or vasodilators); 2. Heart failure-related rehospitalization; 3. Decrease in 6MWD from baseline by \>10% or \>30 meters; 4. Need for heart/lung transplantation; 5. All-cause death
Changes from baseline in pulmonary vascular resistance (right heart catheterization)
Changes from baseline in pulmonary vascular resistance (PVR); Unit of measure: Wood units
Changes from baseline in echocardiographic linear dimension parameters
Changes from baseline in right atrial diameter (RAD), left atrial diameter (LAD), left ventricular internal diameter at end-diastole (LVIDd), left ventricular posterior wall thickness at end-systole (LVPWd), and tricuspid annular plane systolic excursion (TAPSE); Unit of measure: millimeters (mm)
Changes from baseline in echocardiographic percentage functional indices
* Parameters: Ejection fraction (EF), right ventricular fractional area change (RV-FAC) * Unit of measure: percentage (%)
Changes from baseline in cardiac output (right heart catheterization)
* Parameter: Cardiac output (CO) * Unit of measure: liters per minute (L/min)
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