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

Korábbi kezelés

• Anticipated to undergo other surgical or interventional procedures within 6 months;
• Participation in another drug or medical device clinical trial within 3 months prior to screening;

Más betegség

• Cardiac index (CI) < 1.5 L/min/m²;
• Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;
• Acute systemic infectious disease;
• Poor general condition due to various systemic diseases;
• Pulmonary veno-occlusive disease;
• Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;
• Allergy to the drugs or metal materials used in the study;
• Any condition deemed unsuitable for participation in this clinical trial by the investigator. |

Laborértékek

• 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);

Egyéb

• Cachexia;
• Life expectancy <12 months;
• Women who are breastfeeding, pregnant, or planning to become pregnant within one year;

• 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;
• Willing to comply with the treatment and follow-up schedule required by the protocol