Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 3
- 主要终点
- Adverse event rate
研究概览
简要总结
Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases:
Prospective determination of baseline Status Quo (3 months):
Documentation of treatment pathways and endpoints of "routine" patients without educational program
Dedicated reflection and training (1 day):
One training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements.
Implementation of tailored changes (2 months):
Implementation of the changes developed in the training.
Determination of the effect (3 months):
Coordinator measures optimization changes and determines effects.
详细描述
Along the severe aortic stenosis (sAS) treatment pathway there are delays that may impact quality management and hospital efficiency. A dedicated valve coordinator, interfering with all stages of patient handling throughout the hospital may increase the efficiency of the sAS patient flow, accelerate decision making and clinical outcomes while at the same time decreasing resource consumption.
The hypothesis is that the implementation of a dedicated valve coordinator will improve the patient flow of sAS patients scheduled to undergo TAVI, their outcome, patient and physician satisfaction and will optimize costs.
In total, three centers across Germany (Munich, Düsseldorf, Bad Bevensen) will participate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI
排除标准
- •patients not providing written informed consent
结局指标
主要结局
Adverse event rate
时间窗: 30 days
According to VARC-2 criteria.
Patient satisfaction
时间窗: 30 days
Satisfaction score. The total score range is from 0 (extremely dissatisfied) to 40 (extremley satisfied).
Economic evaluation
时间窗: 12 months
Proportion of early discharges in patients with sAS undergoing TAVI.
Evaluation of differences in length of stay (LoS)
时间窗: 12 months
LoS in days.
次要结局
未报告次要终点