NCT05951166进行中（未招募）不适用
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Device related serious adverse events
研究概览
简要总结
Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure with EF ≥ 40% (by TTE within last 3 months)
- •Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest
- •Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
- •Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise
- •Cardiac index (CI) ≥ 1.7 L/min/m2
- •NYHA Class II or III
- •Glomerular Filtration Rate (GFR) ≥ 25 ml/min
- •N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
- •Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
排除标准
- •Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- •Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
- •Systemic infection or localized infection/rash at planned access site at time of procedure
- •Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
- •CRT or other Interventional cardiac procedure (except RHC) within last 3 months
- •Any planned cardiac procedure or inpatient procedure within the next 30 days
结局指标
主要结局
Device related serious adverse events
时间窗: 30 days post-treatment
次要结局
- Mean change from baseline in Pulmonary Vascular Resistance (woods units)(6- months post-treatment)
研究者
研究点 (2)
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