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
- 7
- 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
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 effectiveness(1, 6 and 12 months)
- Clinical efffectivness(6 months)