NCT05758909进行中（未招募）不适用
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Fundación EPIC13 个研究点 分布在 1 个国家目标入组 585 人开始时间: 2023年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 585
- 试验地点
- 13
- 主要终点
- Assessment of early safety
研究概览
简要总结
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
详细描述
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who meet all of the following conditions will be included:
- •Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis.
- •Patients with percutaneous implant.
- •Patients undergoing the procedure under superficial sedation or Local anesthesia.
- •Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier.
- •Patients who have signed the informed consent.
排除标准
- •Patients who do not meet any of the following conditions:
- •Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers.
- •Hospitalized patients undergoing urgent TAVI implantation.
- •Patients with access other than percutaneous transfemoral.
结局指标
主要结局
Assessment of early safety
时间窗: 30 days
Proportion of patients with early safety defined as: * Cardiovascular death. * Stroke. * Myocardial Infarction. * Hospitalization for any reason . * Major vascular complications. * Need for pacemakers.
次要结局
- Assessment of Hospitalization for any reason(12 months)
- Assessment of Stroke(12 months)
- Assessment of Myocardial Infarction(12 months)
- Assessments of need for pacemakers(12 months)
- Assessment of Cardiovascular death(12 months)
- Assessments of Major Vascular Complications(12 months)
- Assessment of hospitalization time(at discharge)
- Assessment of hospitalization due cardiac reasons(30 days)
研究者
研究点 (13)
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