Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)
研究概览
简要总结
Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)
详细描述
OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a single centre, prospective, proof-of-principle, feasibility study performed in the Academic Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All final aortograms will be performed according to predetermined acquisition protocol and analysed immediately after the acquisition in the cath-lab. All aortograms will also be analysed off-line by an independent core laboratory in the Netherlands (Cardialysis, Rotterdam, The Netherlands).
The primary endpoint of the study is the feasibility of the on-line assessment of regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility of results between the on-line assessment and the off-line analysis by the independent core laboratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.
排除标准
- •Patients that were not considered by the Institution's heart team as eligible
结局指标
主要结局
Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)
时间窗: immediately
Feasibility of analysis (percentage of cases considered analyzable by videodensitometry - online). The investigators will assess the percentage of cases that are considered by the investigators as analyzable (i.e., that the investigators are able to perform an on-line analysis of videodensitometry).
Comparison with feasibility of ASSESS-REGURGE ( to compare the percentage of analyzable cases with the percentage of the current standard found in ASSESS-REGURGE - 95.5%)
时间窗: immediately
Since ASSESS-REGURGE has the highest feasibility of analysis with quantitative aortogram, the investigators aim to compare the present feasibility (of OVAL) with the new standard from ASSESS-REGURGE. In other words, the percentage of analyzable cases in the present study will be compared with the percentage of analyzable cases found in ASSESS-REGURGE (95.5% of analyzability).
次要结局
- Comparison of online feasibility with core lab feasibility(immediately)
研究者
Patrick W. Serruys
Professor
Imperial College London