NCT04570228尚未招募不适用
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- SoniVie Inc.
- 入组人数
- 205
- 主要终点
- 6 minute walking distance (6MWD)
研究概览
简要总结
Theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6M, to assess the safety and effectiveness of pulmonary artery denervation with the TIVUS™ System in subjects with PAH. The study will assess improved and/or maintained exercise tolerance in patients with PAH through the analysis of exercise tolerance, hemodynamic changes, clinical worsening and the quality of life who got treated by the TIVUS system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 subject, according to local regulations, prior to initiation of any study mandated procedure.
- •Male or female ≥ 18 years of age at the time of screening
- •Subject with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced, familial PAH or corrected congenital heart defects more than 1 year prior to enrollment, confirmed by right heart catheterization 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 (240 dyne*s/cm^5)
- •Subject is on maximally tolerated medical therapy for PAH, as determined by his PAH physician
- •Subject 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)
- •Subject is able to tolerate IV contrast used for the angiograms during treatment
- •Subject is WHO functional class II or III
排除标准
- •Subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months
- •Subjects with portal-pulmonary hypertension, Group 2, 3 and 4 PH
- •Pregnant women or women planning a pregnancy within 12 months of study enrolment
- •Subject with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry
- •Subject 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)
- •Subject with pulmonary artery anatomy that precludes treatment with the TIVUS System
- •Subject who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
- •Subject experiencing a current episode of acute decompensated heart failure
- •Subject who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrollment.
- •Subject who has implantable Cardiomems device, or other implanted device that might be contraindicated for therapeutic ultrasound energy.
结局指标
主要结局
6 minute walking distance (6MWD)
时间窗: 6 months
Statistical difference in 6MWD between the treated group and the sham control group
The rate of procedure and treatment related SAEs reported
时间窗: 12 months
次要结局
- Difference between the treated group and the sham control group in resting mean right atrial pressure (mRAP)(6 months)
- Difference between the treated group and the sham control group in resting pulmonary vascular resistance (PVR)(6 months)
- Difference between time to clinical worsening event between the treated group and the sham control group(6 months)
- Difference between the treated group and the sham control group in resting cardiac index (CI)(6 months)
- Difference between the treated group and the sham control group in patients' clinical pulmonary arterial hypertension condition defined by worsening of World Health Organization (WHO) functional class(6 months)
- Statistical difference between the treated group and the sham control group in exercise tolerance as measured using the change in activity parameters using the Actigraph Centrepoint watch(6 months)
- Difference between the treated group and the sham control group in resting mean pulmonary artery pressure (mPAP)(6 months)
- Percent of patients who improve or maintain their exercise tolerance (as measured by 6MWD and actigraphy)(6 months)
- Difference between the treated group and the sham control group in Quality of Life (QOL) score using the SF36 questionnaire(6 months)
- Difference between the treated group and the sham control group of NT-pro-BNP levels(6 months)
- Difference between the number of clinical worsening events between the treated group and the sham control group(6 months)
研究者
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