Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease
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
- 6
- 主要终点
- Procedural related Adverse Events (complications) at up to 30 days post procedure
研究概览
简要总结
The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life.
This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
- •Male or female, ≥ 18 years of age at the time of screening
- •Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
- •Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
- •Patient with a current diagnosis of NYHA functional class II/III
- •Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l
排除标准
- •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 experiencing a current episode of acute decompensated heart failure
- •Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.
结局指标
主要结局
Procedural related Adverse Events (complications) at up to 30 days post procedure
时间窗: 30 days
Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.
次要结局
- Change in resting mean right atrial pressure(4 month)
- Change in NT-BNP levels(4 month)
- Change in exercise mean pulmonary artery pressure(4 month)
- Change in resting cardiac index(4 month)
- Change in exercise pulmonary vascular resistance(4 month)
- Changes in cardiopulmonary exercise test(4 month)
- Changes in Echocardiography parameters(4 month)
- Changes in 6MWD from baseline(4 month)
- Change in exercise mean right atrial pressure(4 month)
- Change in resting mean pulmonary artery pressure(4 month)
- Procedure related and PH worsening adverse events(12 month)
- Change in resting pulmonary vascular resistance(4 month)
- Change in exercise cardiac index(4 month)