NCT07662655招募中1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cardiac index (CI) < 1.5 L/min/m²;
- •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);
- •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;
- •Anticipated to undergo other surgical or interventional procedures within 6 months;
- •Life expectancy <12 months;
- •Allergy to the drugs or metal materials used in the study;
- •Women who are breastfeeding, pregnant, or planning to become pregnant within one year;
- •Participation in another drug or medical device clinical trial within 3 months prior to screening;
- •Any condition deemed unsuitable for participation in this clinical trial by the investigator. |
研究者
Xiang Chen
Principal Investigator
Xiamen Cardiovascular Hospital, Xiamen University
研究点 (1)
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