CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,001
- 试验地点
- 56
- 主要终点
- Cardiovascular Mortality
研究概览
简要总结
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
详细描述
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.
Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
- •Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
排除标准
- •Have sepsis, including active endocarditis
- •Have any evidence of left ventricular or atrial thrombus
- •Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- •Have a non-calcified aortic annulus
- •Have congenital bicuspid or unicuspid leaflet configuration
- •Are unable to tolerate antiplatelet/anticoagulant therapy
- •Are pregnant at the time of signing informed consent
- •Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
结局指标
主要结局
Cardiovascular Mortality
时间窗: 30 days from the index procedure
Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
次要结局
- Number Of Subjects With Valve Embolization(At 30 days)
- Number of Subjects With Myocardial Infarction(At 30 days)
- Number of Subjects With Stroke(At 30 days)
- Number of Subjects With Bleeding Events(At 30 days)
- Number of Subjects With Acute Kidney Injury(At 30 days)
- Number of Subjects With Vascular Complications(At 30 days)
- Number of Subjects With Annular Rupture(At 30 days)
- Number of Subjects With Coronary Obstruction(At 30 days)
- Number of Subjects Undergoing Conversion To Open Surgery(At 30 days)
- Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment(At 30 days)
- Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion(At 30 days)
- Vessel Diameter(At 30 days)
- Introducer Sheath Used(At 30 days)
- Implant Success(At 30 days)
- Effective Orifice Area(At 30 days)
- Aortic Valve Mean Gradient(At 30 days)
- Number of Subjects With Paravalvular Leak (PVL)(At 30 days)
- NYHA Classification(At 30 days)
- EQ5D-3L Visual Analog Scale Value(At 30 days)
- Kaplan-Meier Rate of All-cause Mortality(At 12 months)