NCT02838199撤回4 期
Prospective, Open Label, Multicenter, Dual Arm, Randomized Trial of TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis
Seung-Jung Park1 个研究点 分布在 1 个国家开始时间: 2016年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- event rate of all-cause mortality
研究概览
简要总结
The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age must be at least 19 and less than 75 years old
- •Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm
- •Echocardiogram must be within 3 months of the date of the procedure
- •Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater.
- •The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Life expectancy <1 year due to medical illness
- •Suspected Malignancy
- •Inoperability evaluated by surgeon
- •Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention
- •Concomitant severe mitral valve or significant aorta disease requiring surgery
- •Active bacterial endocarditis within 6 months of procedure
- •Leukopenia (WBC<3000 cell/mL), acute anemia (Hgb<8g/dL), thrombocytopenia (platelet < 50000 cell/mL)
- •Intracardiac thrombus
- •A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
- •Native aortic annulus size < 18 mm or > 25 mm as measured by echocardiogram.
- •Expectation that patient will not improve despite treatment of aortic stenosis
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
研究组 & 干预措施
TAVR
Experimental
Transcatheter aortic valve replacement with SAPIEN 3
干预措施: SAPIEN 3 (Device)
SAVR
Active Comparator
Surgical aortic valve replacement
干预措施: SAVR (Procedure)
结局指标
主要结局
event rate of all-cause mortality
时间窗: 1 year
次要结局
- event rate of myocardial Infarction(31 days to the 1 year)
- event rate of acute kidney injury(31 days to the 1 year)
- event rate of other TAVR-related complication(31 days to the 1 year)
- event rate of free from atrial fibrillation(30days and 1 year)
- event rate of bleeding(31 days to the 1 year)
- event rate of vascular access site and access-related complication(31 days to the 1 year)
- event rate of prosthetic valve dysfunction(31 days to the 1 year)
- event rate of composite event for device success, early safety, clinical efficacy(31 days to the 1 year)
- event rate of cardiovascular mortality(31 days to the 1 year)
- event rate of all Stroke and transient ischemic attack(31 days to the 1 year)
- event rate of structural valve deterioration(31 days to the 1 year)
- NYHA (New York Heart Association Functional Classification)(30days and 1 year)
- event rate of permanent pacemaker insertion(31 days to the 1 year)
- Valve area(30days and 1 year)
- event rate of myocardial Infarction(30 days or hospital discharge, whichever is longer)
- event rate of all Stroke and transient ischemic attack(30 days or hospital discharge, whichever is longer)
- event rate of cardiovascular mortality(30 days or hospital discharge, whichever is longer)
- event rate of bleeding(30 days or hospital discharge, whichever is longer)
- event rate of vascular access site and access-related complication(30 days or hospital discharge, whichever is longer)
- event rate of acute kidney injury(30 days or hospital discharge, whichever is longer)
- event rate of permanent pacemaker insertion(30 days or hospital discharge, whichever is longer)
- event rate of other TAVR-related complication(30 days or hospital discharge, whichever is longer)
- event rate of prosthetic valve dysfunction(30 days or hospital discharge, whichever is longer)
- event rate of composite event for device success, early safety, clinical efficacy(30 days or hospital discharge, whichever is longer)
- event rate of structural valve deterioration(30 days or hospital discharge, whichever is longer)
研究者
Seung-Jung Park
professor of medicine
Asan Medical Center
研究点 (1)
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