NCT03225001已完成不适用
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
Edwards Lifesciences92 个研究点 分布在 2 个国家目标入组 197 人开始时间: 2012年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 92
- 主要终点
- Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
研究概览
简要总结
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
详细描述
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m
- •Qualifying echo must be within 60 days of the date of the procedure.
- •Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- •The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- •The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
- •Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
排除标准
- •Bioprosthetic valve labeled external diameter < 21mm.
- •Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
- •Infectious endocarditis within 6 months.
- •Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
结局指标
主要结局
Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
时间窗: 30-day
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
次要结局
- Number of Participants With Mortality From Any Cause(30 Days)
研究者
研究点 (92)
Loading locations...
相似试验
已完成
不适用
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High RiskSymptomatic Severe Aortic StenosisNCT01314313Edwards Lifesciences2,032
已完成
不适用
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7Symptomatic Severe Aortic StenosisNCT03222141Edwards Lifesciences583
已完成
不适用
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 IntermediateSymptomatic Severe Aortic StenosisNCT03222128Edwards Lifesciences1,074
进行中（未招募）
不适用
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic StenosisAortic StenosisNCT02675114Edwards Lifesciences1,000
已完成
不适用
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic StenosisSevere Symptomatic Aortic StenosisNCT01787084The Society of Thoracic Surgeons8