NCT06495970招募中不适用
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Device related serious adverse events
研究概览
简要总结
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
详细描述
The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
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
- •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
- •NYHA Class II or III
- •Glomerular Filtration Rate (GFR) ≥ 25 ml/min
排除标准
- •Unwilling to provide informed consent or complete follow-up assessments
- •Life expectancy of < 2 years
- •Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- •Unable to tolerate right heart catheterization
- •Severe aortic, mitral or pulmonary valve regurgitation
- •Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
- •Systemic infection or localized infection/rash at planned access site at time of procedure
- •CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months
结局指标
主要结局
Device related serious adverse events
时间窗: 30-days post-treatment
Frequency of device related SAEs
次要结局
- Mean change from baseline in Pulmonary Vascular Resistance (woods units)(6 month post-treatment)
研究者
研究点 (6)
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