Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Device related serious adverse events
研究概览
简要总结
This early feasibility study is intended to 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
Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.
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
- •Stable, guideline directed medical treatment, including controlled volume status for a minimum of 1 months prior treatment
排除标准
- •Ambulatory with a Life expectancy of < 1 years
- •Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- •Unable to tolerate right heart catheterization
- •Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
- •Severe aortic, mitral or pulmonary valve regurgitation
- •Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
- •Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
研究组 & 干预措施
PADN with Gradient Denervation System
Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
干预措施: Gradient Denervation System (Device)
结局指标
主要结局
Device related serious adverse events
时间窗: Through 30 days post-treatment
Frequency of SAEs deemed to be related to the investigational device and/or procedure.
次要结局
- Mean change from baseline in Pulmonary Vascular Resistance (woods units)(Measured at 6 months post-treatment)