Pulmonary Arterial Hypertension
Conditions
Interventions
Surgery group:Participants in the experimental arm will receive percutaneous balloon atrial septostomy, performed by experienced interventional cardiologists following standard procedural protocols. A
Control group:In control group, participants will receive guideline-directed optimized pharmacologic therapy for severe pulmonary arterial hypertension, including triple or more targeted PAH therapies
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–70 years. 2. Diagnosis of one of the following: idiopathic PAH, heritable PAH, pulmonary arterial hypertension associated with congenital heart disease(CHD-PAH, repaired at least 1 year), or connective tissue disease–associated pulmonary arterial hypertension (CTD-PAH). 3. Patients remain in the intermediate-high or high-risk group per the ESC/ERS four-strata risk model despite optimized triple PAH-targeted therapy(ERAs+PDE5i/Riociguat+SC Treprostenil or Oral Selexipag). 4. Resting arterial oxygen saturation (SaO2) > 85% on room air. 5. Right heart catheterization parameters: mean pulmonary arterial pressure (mPAP)>= 30 mmHg, pulmonary artery wedge pressure (PAWP) = 3 Wood units, and right atrial pressure (RAP) =< 25 mmHg. 6. Ability to comply with study visits, treatment plans, laboratory assessments, and other study procedures. 7. Voluntary participation with signed informed consent, indicating that the patient understands the study purpose, procedures, potential risks, and agrees to undergo the intervention and complete follow-up as required.
Exclusion criteria
Exclusion criteria: 1. Severe underlying pulmonary disease affecting oxygen saturation. 2. Inability to lie flat even with supplemental oxygen. 3. Severe coagulation disorders or contrast agent allergy preventing cardiac interventional procedures. 4. Active, uncontrolled infection prior to intervention. 5. Acute or chronic organic or psychiatric conditions preventing patient cooperation. 6. Malignancy or other severe comorbidities with an expected survival of less than 1 year. 7. Inability or refusal to comply with study requirements or to provide informed consent. 8. History of conditions that may affect protocol adherence, such as severe mental disorders, cognitive impairment, or substance abuse/addiction. 9. Any other condition deemed by the investigator to make participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-month transplant-free survival (post-procedure); | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year all-cause mortality;3-year event-free survival;6-month LVEDD/RVEDD changes;1-year all-cause mortality;1-year event-free survival;perioperative BAS complications;30-day post-BAS mortality;Pulmonary hypertension-related rehospitalization rate; | — |
Countries
China
Contacts
Public ContactZhicheng Jing
Guangdong Provincial People's Hospital
Outcome results
None listed