Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- SoniVie Inc.
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Amount of treatment related adverse event as assessed by the CEC
研究概览
简要总结
The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH, connective tissue disease PAH, Anorexogen induced or Heritable PAH
- •PAH diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest; Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg; Pulmonary vascular resistance (PVR) at rest >3 Wood units; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤ 40 mmHg).
- •Patient with a current diagnosis of WHO functional class III
- •Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids
- •Patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
- •Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l
排除标准
- •Patients who are treated with parenteral prostanoids
- •Pregnant women or women planning a pregnancy within 12 months of study enrolment
- •Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
- •Patient with life expectancy of less than a year
- •Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
- •Patient with pulmonary artery anatomy that precludes treatment
- •Patient with moderate to severe pulmonary artery stenosis
- •Patient with any pulmonary artery aneurysm
- •Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
- •Patient who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices
- •Patients who are unable to undergo an MRI scan
研究组 & 干预措施
Pulmonary Denervation
Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary arterial hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.
干预措施: Therapeutic Intra-Vascular UltraSound (TIVUS™) System (Device)
结局指标
主要结局
Amount of treatment related adverse event as assessed by the CEC
时间窗: 12 month
All treatment related adverse events
Amount of all procedural related adverse event as assessed by the CEC
时间窗: 1 month
Procedural related Adverse Events
Number of patient with PAH worsening and all cause death events
时间窗: 12 month
PAH related adverse events and all cause death
次要结局
- Clinical efffectivness(6 months)
- Clinical effectiveness(1, 6 and 12 months)
- Clinical effectiveness(6 months)