NCT06542380已完成不适用
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
German Heart Institute1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Pacemaker Implantation
研究概览
简要总结
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 51 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020
排除标准
- •previous device implantation
- •valve-in-valve procedure
- •patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)
结局指标
主要结局
Pacemaker Implantation
时间窗: 30 days after TAVI
Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines
次要结局
未报告次要终点
研究者
Julia Lueg
Principal Investigator
German Heart Institute
研究点 (1)
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