A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke
研究概览
简要总结
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
详细描述
The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.
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 —（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 ViV indication due to a failed bioprosthetic valve.
- •Patient is at risk for TAVR-induced coronary artery ostium obstruction.
- •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, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements.
- •Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure.
- •CVA or TIA ≤ 6 months prior to index procedure.
- •History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
- •LVEF < 30%.
- •Ongoing severe infection or sepsis.
- •Patient has renal insufficiency or is on chronic dialysis.
- •8. Need for emergency surgery for any reason.
- •Life expectancy is less than 1 year.
研究组 & 干预措施
Shortcut
Splitting bioprosthetic aortic valve leaflets
干预措施: Shortcut (Device)
结局指标
主要结局
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke
时间窗: discharge or at 7 days post-procedure, whichever occurs first
Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography
时间窗: Intra-procedure
Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
次要结局
- Rate of All Cause Mortality, Per VARC 3(30 days post procedure)
- Rate of All-cause Stroke, Per VARC-3(30 days post procedure)
- Rate of Coronary Obstruction Per VARC-3(30 days post procedure)
- Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3(30 days post procedure)
- -Rate of Major Vascular Complications Per VARC-3(30 days post procedure)
- Rate of Cardiac Temponade Per VARC-3(30 days post procedure)
- Rate of Acute Kidney Injury Per VARC-3(30 days post procedure)
- Access-related Type 3-4 Bleeding Per VARC-3(30 days post procedure)
- Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet(30 days post procedure)
- Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet(30 days post procedure)
- Shortcut Technical Success(At exit from procedure room, immediately after the procedure)