Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 554
- 试验地点
- 4
- 主要终点
- MACE
研究概览
简要总结
The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.
详细描述
Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.
Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.
Karolinska will be the coordinating center for data collection.
Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).
Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).
排除标准
- 未提供
结局指标
主要结局
MACE
时间窗: 30 days
any of * Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported) * Postoperative new permanent pacemaker (in hospital) * 30 days mortality * 30 days stroke * Acute Kidney Injury (AKIN grade 3) (in hospital)
次要结局
- Rate of Postoperative aortic insufficiency more than mild by aortography(Same day as procedure)
- Postoperative aortic valve gradients(Within 7 days of procedure)
- Procedural contrast use(Same day as procedure)
- Rate of Postoperative aortic insufficiency more than mild by transthoracic echo(Within 7 days of procedure)
- Rate of major acute procedural complications(Same day as procedure)
研究者
Andreas Rück
Principal Investigator
Karolinska University Hospital