Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Composite of all-cause death and hospitalization for worsening heart failure
研究概览
简要总结
LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) and, in particular:
- risk factors
- gender differences
- comorbidities
- pharmacological treatment
- TAVR procedural characteristics
- periprocedural and in-hospital complications
- clinical outcome at 30-day, 1-year, 2-year and 5-year follow-up
详细描述
LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).
The register aims to include at least 1,500 patients diagnosed with LFLG-AS undergoing TAVR at the participating centres.
The inclusion criteria are:
- LFLG-AS diagnosis according to current European Society of Cardiology guidelines
- Age 18 years or older
- Written informed consent
The exclusion criteria are:
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
- •LFLG-AS diagnosis according to current European Society of Cardiology guidelines
- •Age 18 years or older
- •Written informed consent
排除标准
- •LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
- •LFLG-AS referred for medical treatment or undergoing surgery
结局指标
主要结局
Composite of all-cause death and hospitalization for worsening heart failure
时间窗: 1 year
Death due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure
次要结局
未报告次要终点
研究者
Gennaro Galasso
Professor
University of Salerno