# Study Design

a prospective, multicenter, multinational, randomized, controlled trial comparing the safety and effectiveness of the PASCAL system with the MitraClip system in patients at prohibitive surgical risk with significant symptomatic DMR.

一项前瞻性、多中心、跨国、随机对照试验，比较 PASCAL 系统和 MitraClip 系统对手术风险过高且有明显症状的 DMR 患者的安全性和有效性

Eligible patients had ≥3+ DMR, left ventricular ejection fraction (LVEF) ≥20%, left ventricular end-diastolic dimension ≤80 mm, and noncomplex MV anatomy, deemed suitable for treatment with both the PASCAL and MitraClip systems
合格患者的 DMR 为 ≥3+，左心室射血分数（LVEF）为 ≥20%，左心室舒张末期尺寸为 ≤80 毫米，中压解剖结构不复杂，适合使用 PASCAL 和 Mitra Clipsystems 治疗。

The trial randomized 300 patients at a 2:1 ratio (PASCAL, MitraClip) with follow-up at discharge, 30 days,6 months,1year,and annually to 5years

A Bayesian adaptive design was used to allow for analysis of study success before reaching the full sample size.
采用贝叶斯适应性设计，以便在达到全部样本量之前对研究的成功与否进行分析。

Study oversight included an independent echocardiography core laboratory, central screening committee, data and safety monitoring board, and a clinical events committee.
研究监督包括独立的超声心动图核心实验室、中央筛选委员会、数据和安全监督委员会以及临床事件委员会。

All patients provided written informed consent. The study received due ethical oversight with respective site Institutional Review Board and ethics committee approvals, and conformed to the Declaration of Helsinki, Good Clinical Practice principles, and ISO (International Organization for Standardization) 14155:2011
所有患者均提供了书面知情同意书。这项研究得到了相关研究机构审查委员会和伦理委员会的批准，并符合《赫尔辛基宣言》、《良好临床实践》原则和 ISO（国际标准化组织）14155:2011 标准。

The trial sponsor, Edwards Lifesciences Corp., participated in site selection, trial management, and data analysis.
试验赞助商 Edwards Lifesciences 公司参与了中心选择、试验管理和数据分析。

# Echo assessments

independent echocardiography core laboratory (Cardiovascular Core Lab at Morristown Medical Center, Atlantic Health System, Morristown, New Jersey, USA)
独立的超声心动图核心实验室（美国新泽西州莫里斯镇大西洋健康系统莫里斯镇医疗中心心血管核心实验室）

screening/baseline transthoracic echocardiography (TTE) and transesophageal echocardiography to confirm the presence of ≥3+ DMR along with other echocardiographic eligibility parameters, and for all follow-up TTE studies
筛查 / 基线经胸超声心动图（TTE）和经食道超声心动图，以确认是否存在 ≥3+ DMR 以及其他超声心动图合格参数，并进行所有后续 TTE 检查

All participating sites were encouraged to perform 3-dimensional (3D) MV evaluations in accordance with the core laboratory specified image acquisition protocol and were requested to submit raw 3D data to allow for multiplanar reconstruction (MPR) of echocardiographic planes of interest.
我们鼓励所有参与研究的机构按照核心实验室指定的图像采集协议进行三维（3D）超声心动图评估，并要求他们提交原始三维数据，以便对感兴趣的超声心动图平面进行多平面重建（MPR）。

MR grading at screening was performed by integrating all available quantitative, semiquantitative, qualitative, and supplemental echocardiographic parameters based on current American Society of Echocardiography (ASE) guidelines
筛查时的磁共振分级是根据美国超声心动图学会（ASE）的现行指南，综合所有可用的定量、半定量、定性和补充超声心动图参数进行的

An MR grade of 3+ was assigned in cases where quantitative parameters were in the “high moderate” range but short of the severe range(effectiveregurgitantorifice area [EROA] = 0.30-0.39 cm2; regurgitant volume [RegVol] = 45-59 mL; regurgitant fraction = 40%-49%), and most semiquantitative and qualitative parameters pointed toward severe MR.”
如果定量参数在 "高中度" 范围内，但未达到重度范围（有效反流孔面积 [EROA] 0.30-0.39 cm2；反流容积 [RegVol] 45-59 mL；反流分数 40%-49%），且大多数半定量和定性参数指向重度 MR，则 MR 等级为 3+。

A frame rate of ≥10 Hz was required for color 3D data sets, and the highest frame rates were selected for measurements that vary significantly with the cardiac cycle.
彩色 3D 数据集的帧频要求为 ≥10 赫兹，对于随心动周期变化较大的测量，则选择最高帧频。

If adequate, 3D vena contracta area (VCA) was used as a surrogate for EROA in MR quantitation.
如果足够大（帧频？），三维静脉收缩面积（VCA）被用作 MR 定量中 EROA 的替代物。

Additional considerations included systolic variation in MR severity (nonholosystolic MR), blood pressureatthetimeofthestudy,andtechnicalfactors such as color Doppler gain, scale, and flow optimization settings.
其他考虑因素包括 MR 严重程度的收缩期变化（非酒精性 MR）、研究时的血压以及彩色多普勒增益、刻度和流量优化设置等技术因素。

Borderline cases were reviewed and adjudicated by consensus among the level III echocardiographers in the core laboratory.
核心实验室的三级超声心动图医师对有争议的病例进行了审查，并达成了一致意见。

Flail segments were analyzed in orthogonal planes at peak systolic excursion
在正交平面上对收缩期偏移峰值的瓣膜进行分析

Flail width was measured in the commissural plane, and flail gap was measured in the orthogonal long-axis view from the flail leaflet tip down to the opposing leaflet, perpendicular to the mitral annulus.
瓣叶宽度在连合平面测量，瓣叶间隙在正交的长轴切面测量，从瓣叶尖端向下至对侧瓣叶，垂直于二尖瓣环

3D MPR was preferentially used for mitral valve area (MVA) planimetry because of its precision in locating the imaging plane of interest.
由于 3D MPR 能精确定位感兴趣的成像平面，因此优先用于二尖瓣面积 (MVA) 平面测量。

Planimetry was performed at the leaflet tips (narrowest point) during maximal opening of the MV.
在 MV 最大打开时，在瓣叶尖端（最窄处）进行平面测量。

3D MPR planimetry was also required if 2D-dimensional MVA was <5.0 cm2.
如果二维 MVA 小于 5.0 平方厘米，还需要进行三维 MPR 平面测量。

Posterior mitral leaflet (PML) length was measured from the effective hinge point at or near the annulus to the primary chord insertion at the tip of posterior leaflet.
后瓣膜小叶（PML）的长度是从瓣环处或附近的有效铰链点到后瓣膜小叶顶端的初级腱索插入处测量的。

If the leaflet length was not uniform across PML scallops (often as a result of focally encroaching mitral annular calcification [MAC]), the plane of interest was reconstructed using 3D MPR, and the leaflet length was measured in the “ideal” grasping view.
如果 PML 扇贝上的瓣叶长度不一致（通常是由于二尖瓣瓣环钙化 [MAC] 的局部侵蚀），则使用 3D MPR 重建感兴趣平面，并在 "理想" 抓取视图中测量瓣叶长度。

Blunting of systolic flow in pulmonary veins (PVs) was graded “mild” if systolic peak velocity was ≥50% of the diastolic peak velocity and “severe” if it was <50%.”
如果收缩期峰值速度为舒张期峰值速度的 ≥50%，则肺静脉（PV）收缩期血流钝化被评为 "轻度"；如果收缩期峰值速度小于舒张期峰值速度的 <50%，则肺静脉收缩期血流钝化被评为 "重度"。

MAC was assessed qualitatively using TTE short-axis views at the base, and it was graded as mild, moderate, or severe based on its circumferential extent of up to one-third, two-thirds, or more than two-thirds of the mitral annular circumference, respectively
使用 TTE 底部短轴切面对 MAC 进行定性评估，并根据其周缘范围分别为二尖瓣环周的三分之一、三分之二或三分之二以上，将其分为轻度、中度或重度。

All echocardiographic parameters were assessed in accordance with the current ASE guidelines
所有超声心动图参数均按照现行 ASE 指南进行评估，附加文档