Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study

Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study

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

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. |