A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Primary Safety Assessment
研究概览
简要总结
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
- To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
- To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 22 years of age.
- •Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
- •Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
- •Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations
排除标准
- •Any contraindication as specified in the approved device label.
- •An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
- •Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
- •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, as determined by the investigator.
- •Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- •Hemodynamic or respiratory instability.
- •Left ventricle ejection fraction < 30%.
- •Ongoing severe infection, sepsis or endocarditis.
- •Patient has renal insufficiency (GFR < 30 ml/min or serum creatinine > 2.5 mg/dL), or on chronic dialysis.
- •Need for emergency surgery for any reason.
- •Life expectancy is less than 1 year.
结局指标
主要结局
Primary Safety Assessment
时间窗: At discharge or 7 days post-procedure, whichever occurs first
Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC): * Cardiovascular Mortality * All Stroke
Primary Effectiveness Assessment
时间窗: Immediately after TAVR procedure
Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.
次要结局
未报告次要终点