Transcatheter Aortic Valve Intervention-Live Transmission (VERITAS)Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
研究概览
简要总结
The primary objective of this clinical trial is to evaluate safety of patients who underwent Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission as compared to those without procedure transmission.
详细描述
A series of sites from outside the US, where the Edwards-Sapien and CoreValve devices are approved for commercial sale and implantation, will be recruited to retrospectively identify and extract in-hospital data of a patient who underwent TAVI during a live or video-taped procedure and a matched patient who underwent TAVI without transmission of the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Subjects > 18 years of age, male or female
- •Subject had live case or video-taped transmission of TAVI procedure with:
- •Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach
- •Controls Inclusion Criteria:
- •Subjects > 18 years of age, male or female
- •Subject underwent TAVI without procedure transmission and had:
- •Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach
- •Subjects will be matched to Cases upon the following:
- •STS SCORE +/- 2points
- •Date of TAVI procedure +/- 4weeks
- •The first attending for the TAVI procedure
- •Access site for TAVI
排除标准
- 未提供
结局指标
主要结局
Major complication defined as in hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, and the need for a pacemaker.
时间窗: Baseline
次要结局
未报告次要终点