Calcium Algorithm Sizing for bicusPid Aortic Valve Evaluation With Raphe: the CASPER Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Efficacy of the CASPER algorithm
研究概览
简要总结
The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29) and Evolut® R 34.
详细描述
STUDY DESIGN
This is an Investigator initiated, international, multicenter, prospective registry, enrolling 100 consecutive BAV patients who will undergo TAVI with the Evolut R/Pro (23-26-29)/Evolut R 34THV.
Enrollment will be without limitation for each center (competitive enrollment). The indication for TAVI will be based on each local Heart Team decision. As per local institution's regulatory policy, each patient will provide a written informed consent for the TAVI procedure, anonymous data collection and analysis. Each center will use its own consent template.
All data will be collected in an electronic clinical report form (eCRF).
STUDY POPULATION Population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥18 years.
- •NYHA≥2 and/or syncope and/or angina.
- •Patient judged by the Heart Team as indicated for TAVI.
- •Anatomical suitability for transfemoral or any alternative access TAVI, based on MSCT assessment and local expertise and preference.
- •Estimated life expectancy>1 year.
排除标准
- •Age <18 years
- •Estimated life expectancy<1 year
- •Pure aortic regurgitation.
- •No baseline MSCT evaluation.
结局指标
主要结局
Efficacy of the CASPER algorithm
时间窗: 1 year
The objective of the study is to validate the CASPER algorithm in a prospective cohort using a self-expandable THV, in order to assess the safety and efficacy of bicuspid aortic valve sizing based on calcium burden and raphe length.
次要结局
- Safety of the CASPER algorithm(1 year)
研究者
Anna Sonia Petronio
Professor
University of Pisa