PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation: The PROSPERO-TAVI Multi Center, International Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Absolute difference in maximum aortic diameters at multiple levels of ascending aorta
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. Although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (BAV) are commonly treated in daily TAVI practice. Indeed, several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve (TAV) patients. Notably, BAV is frequently associated with aortic dilatation (20% to 84% of BAV patients). Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). TAVI patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment (6,7).
The main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography (CTA) assessment at follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing TAVI with native BAV from January 2018 to December 2019
排除标准
- •Patients undergoing TAVI without native BAV
- •Patients receiving first generation TAVI device
- •Patients undergoing TAVI before January 2018 or after December 2019
结局指标
主要结局
Absolute difference in maximum aortic diameters at multiple levels of ascending aorta
时间窗: 5 years
Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment
次要结局
- Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)(5 years)
- Death, stroke or rehospitalization for heart failure(5 years)
- Aortic events leading to urgent intervention or elective aortic root replacement(5 years)
研究者
Giuliano Costa
Principal Investigator
University of Catania