Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 14
- 主要终点
- Observed Mean (Std Err) for % Difference Between VMS and MRI.
研究概览
简要总结
The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (RVEDV and RVESV) in subjects with Pulmonary Arterial Hypertension (PAH). The trial will be defined as positive if the mean VMS-cMRI percent difference is <10% and >-10% at a 1-sided 0.025 statistical significance level for RVEDV and for RVESV, with no safety concerns for the VMS procedure.
详细描述
The objective of this study is: The comparison of the VMS and MRI values for EDV, ESV, and EF using 75 subjects.
Secondary objectives are:
The determination of VMS inter-observer and intra-observer variability of these quantities using 30 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Group 1 Pulmonary Arterial Hypertension
- •APAH-PoPH
- •APAH-Drugs/Toxins
- •APAH-CHD repaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA
- •APAH-CHD unrepaired simple systemic to pulmonary shunts, i.e. ASD, VSD and/or PDA Patients who can be expected to lie motionless during imagine Males and females 12 years of age and older
排除标准
- •Lack of informed consent (and assent as appropriate)
- •Other forms of PH not included in inclusion criteria
- •Left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, LV systolic dysfunction, i.e. LVEF <40% or LVSF <22%, and/or clinically significant LVDD
- •Known/detected arrhythmia that interferes with image acquisition
- •Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
- •Pregnant or breast-feeding females
- •Contraindications for MRI (for those patient that undergo MRI)
- •Clinically significant obstructive or restrictive lung disease
- •Subjects with known HIV infection who have any clinical or laboratory evidence of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias)
- •PAH associated with thyroid disorders, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy
- •Any subjects with congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria
- •PAH associated with significant venous or capillary involvement (PCWP ˃ 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
- •Clinically significant cardiac ischemic disease
- •Systemic hypertension defined as SBP ˃ 160 mmHg and/or DBP ˃ 95 mmHg (treated or untreated)
- •Moderate or severe hepatic impairment, i.e., Child-Pugh Class B or C
- •Any subject with obstructive sleep apnea or who requires the use of CPAP or BiPAP device
结局指标
主要结局
Observed Mean (Std Err) for % Difference Between VMS and MRI.
时间窗: VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.
% Difference was measured for right ventricular EDV, ESV and EF.
次要结局
- Inter-Observer Variability(VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.)
- Intra-Observer Variability(VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.)