💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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. \|
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