NCT04952909已完成不适用
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)
Pi-cardia23 个研究点 分布在 5 个国家目标入组 60 人开始时间: 2022年1月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 23
- 主要终点
- (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
研究概览
简要总结
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve.
- •Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.
排除标准
- •An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.
- •Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
- •Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure, or severe neurological disability.
- •Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- •Hemodynamic or respiratory instability.
- •Left ventricle ejection fraction < 30%.
- •Ongoing severe infection, sepsis or endocarditis.
- •Renal insufficiency
- •Need for emergency surgery for any reason.
- •Life expectancy is less than 1 year.
研究组 & 干预措施
ShortCut™
Experimental
干预措施: ShortCut™ (Device)
结局指标
主要结局
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
时间窗: Discharge or at 7 days post-procedure, whichever occurs first
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device
时间窗: Intra-procedure
Assessed by echo and/or angiography
次要结局
- (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet(30 days post index procedure)
- (Number of Patients With) All-cause Mortality(30 days post procedure)
- (Number of Patients With) All-cause Stroke(30 days post procedure)
- (Number of Patients With) Coronary Obstruction(30 days post procedure)
- (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention(30 days post procedure)
- (Number of Patients With) Major Vascular Complications(30 days post procedure)
- (Number of Patients With) Cardiac Tamponade(30 days post procedure)
- (Number of Patients With) Acute Kidney Injury(30 days post procedure)
- (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet(30 days post index procedure)
- (Number of Patients With) Access-related Type 3-4 Bleeding(30 days post procedure)
- (Number of Patients With) ShortCut™ Technical Success(At exit from procedure room)
研究者
研究点 (23)
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