Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF
Conditions
Brief summary
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
Interventions
DEVICEPercutaneous Pulmonary Artery Denervation (PADN)
\*\*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PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A,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)
Sponsors
Xiamen Cardiovascular Hospital, Xiamen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤80 years; 2. 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; 3. No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias); 4. Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information; 5. Willing to comply with the treatment and follow-up schedule required by the protocol
Exclusion criteria
1. Cardiac index (CI) \< 1.5 L/min/m²; 2. Severe renal insufficiency (creatinine clearance rate (CrCL) \< 30 mL/min); 3. Left ventricular ejection fraction (EF) \<30% on echocardiography; 4. Severe hematological disease or severe bleeding tendency (platelet count \<10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage); 5. Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment; 6. Acute systemic infectious disease; 7. Poor general condition due to various systemic diseases; 8. Pulmonary veno-occlusive disease; 9. Cachexia; 10. Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension; 11. Anticipated to undergo other surgical or interventional procedures within 6 months; 12. Life expectancy \<12 months; 13. Allergy to the drugs or metal materials used in the study; 14. Women who are breastfeeding, pregnant, or planning to become pregnant within one year; 15. Participation in another drug or medical device clinical trial within 3 months prior to screening; 16. Any condition deemed unsuitable for participation in this clinical trial by the investigator. \|
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical worsening event | From enrollment up to 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in pulmonary vascular resistance (right heart catheterization) | From enrollment up to 12 months | Changes from baseline in pulmonary vascular resistance (PVR); Unit of measure: Wood units |
| Changes from baseline in echocardiographic linear dimension parameters | From enrollment up to 12 months | 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 | From enrollment up to 12 months | * Parameters: Ejection fraction (EF), right ventricular fractional area change (RV-FAC) * Unit of measure: percentage (%) |
| Changes from baseline in cardiac output (right heart catheterization) | From enrollment up to 12 months | * Parameter: Cardiac output (CO) * Unit of measure: liters per minute (L/min) |
| Changes from baseline in WHO functional class | From enrollment up to 12 months | — |
| Changes from baseline in NT-proBNP/BNP | From enrollment up to 12 months | — |
| Changes from baseline in 6-minute walk distance (6MWD) | From enrollment up to 12 months | — |
| Changes from baseline in Short Form-36 (SF-36) Health Survey scale score | From enrollment up to 12 months | The SF-36 scale ranges from 0 to 100, where higher scores indicate a better outcome (Minimum = 0, Maximum = 100). |
| All-cause rehospitalization rate | From enrollment up to 12 months | — |
| Incidence of worsening heart failure symptoms requiring intravenous therapy | From enrollment up to 12 months | — |
| Heart failure-related rehospitalization rate | From enrollment up to 12 months | — |
| Rate of need for heart/lung transplantation | From enrollment up to 12 months | — |
| Changes from baseline in intracardiac pressure parameters (right heart catheterization) | From enrollment up to 12 months | * Parameters: mean right atrial pressure (mRAP), right ventricular systolic pressure (RVSP), pulmonary artery systolic pressure (PASP), pulmonary artery diastolic pressure (PADP), mean pulmonary artery pressure (mPAP), pulmonary artery wedge pressure (PAWP) * Unit of measure: millimeters of mercury (mmHg) |
| Changes from baseline in cardiac index (right heart catheterization) | From enrollment up to 12 months | * Parameter: Cardiac index (CI) * Unit of measure: liters per minute per square meter (L/min/m²) |
| Changes from baseline in pulmonary arterial compliance (right heart catheterization) | From enrollment up to 12 months | * Parameter: Pulmonary arterial compliance (PAC) * Unit of measure: milliliters per millimeter of mercury (mL/mmHg) |
Countries
China
Contacts
CONTACTXiang CHEN, Dr
Outcome results
None listed