RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Safety-Percentage of Treatment patients experiencing major device-related adverse events
研究概览
简要总结
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.
详细描述
This is a multi-national, multi-center, prospective, non-randomized, open label trial of patients implanted with the study device. A total of up to 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.
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
- •Main Inclusion Criteria:
- •Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
- •WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
- •Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.
排除标准
- •Resting oxygen saturation <90 % without supplemental oxygen corrected for altitude.
- •Mean Right Atrial Pressure >20 mmHg.
- •Severe restrictive or obstructive lung disease.
- •Evidence of organ dysfunction other than right heart failure.
- •Left ventricular ejection fraction <40 %.
- •Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
- •Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
- •Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.
研究组 & 干预措施
Therapy: V-Wave Shunt
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.
干预措施: V-Wave Interatrial Shunt (Device)
结局指标
主要结局
Safety-Percentage of Treatment patients experiencing major device-related adverse events
时间窗: 3 months
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
Safety-Percentage of Treatment patients experiencing any major adverse event
时间窗: 3 months
Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
Procedure Success-Percentage of patients successfully implanted with study device
时间窗: 3 months
Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations
Device Success-Percentage of patients implanted with right to left interatrial flow
时间窗: 3 months
Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months
次要结局
- Freedom from device related MACNE at 1 and 12 months after implantation(1 and 12 months)
- Improvement in WHO Functional Class between baseline and 12 months(12 months)
- Improvement in Exercise Capacity between baseline and 12 months(12 months)
- Improvement in Quality of Life between baseline and 12 months(12 months)