Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The bioprosthetic aortic valve replacement is a frequent intervention because of the predominance of calcified aortic stenosis, which is the most common valvular disease, and aging of the population.
International guidelines recommend anticoagulant therapy during the 3 postoperative months, but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the low level of evidence available studies and their sometimes conflicting conclusions.
Questionnaires sent to practitioners have highlighted discrepancies between common practices and recommendations.
However, there is no analysis of actual patterns of postoperative anticoagulation after aortic valve replacement with bioprosthesis.
The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.
详细描述
The study will include consecutive patients who agreed to participate in the study, which meet the criteria for inclusion, that is to say consecutive patients operated on by a bioprosthetic aortic valve replacement during the 3 months of inclusion. Patients will be included immediately after completion of aortic valve replacement.
The data will be entered directly by the referent of each center, based on data from the French Society of Cardiology accessible by Internet on a secure site.
The follow-up time will be 6 months
The incidence of thromboembolic complications and bleeding and mortality within 6 months will be analyzed in a standardized manner according to the recommendations on the analysis of morbidity and mortality after valve surgery.
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
- •Age ≥ 18 years old
- •Patients operated on for single bioprosthetic aortic valve replacement during the study period:
- •with or without reinforcement
- •with or without associated CABG
- •with or without action on the ascending aorta
- •whether a first intervention or reoperation
- •Patients who agreed to participate in the study
排除标准
- •Replacement aortic valve homograft or autograft
- •Surgical procedures on another valve (conservative or prosthetic replacement)
- •Permanent Atrial Fibrillation
- •Processing anticoagulant vitamin K-long course
结局指标
主要结局
Mortality
时间窗: 6 months
次要结局
- Hemorragic and thrombo-embolitic complications(6 months)
研究者
Bernard IUNG
Professor
French Cardiology Society