Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Occurence of permanent pacemaker implantation after TAVI in high risk patients
研究概览
简要总结
There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI
Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. Additional assessment of calcification using a CT data core lab. Statistical analysis of the dataset obtained with respect to the objectives of the registry.
详细描述
Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure.
While a number of registries have documented the rates of PPI with different valves, much less evidence has been provided for
- patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for
- procedural variables (e.g. implantation hieght, valve size etc.) that should be considered to perform as safe and minimal invasive procedure as possible.
Prior Research To date there are 8 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV.
These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% based on patient numbers between 131 and 335 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing transfemoral SAPIEN 3 implantation because of aortic stenosis,
- •at least 1 of the identified risk factors from the retrospective part to ensure a minimum risk of 33% for PPI (presumed: pre-existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, QRS duration or short membranous septum,to be confirmed);
排除标准
- •exclusion of patients with prior pacemaker,
- •with indications for pacemaker implantation prior to TAVI
- •valve in valve implantation or
- •without informed consent
结局指标
主要结局
Occurence of permanent pacemaker implantation after TAVI in high risk patients
时间窗: 1 year
Need for permanent pacemaker implantation after TAVI in high risk patients.
次要结局
- Valve sizing(up to 30 days after intervention)
- Dilatation(1 year)
- Expiration data(2 years)
- Implantation depth(up to 30 days after intervention)