跳至主要内容
临床试验/NCT03259945
NCT03259945
已完成
不适用

Retrospective Observational Study of Patients With a Sutureless Aortic Valve Implanted in the Cardiovascular and Thoracic Surgery Department of Dijon CHU

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 198 人2017年2月16日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Patients With a Sutureless Aortic Valve
发起方
Centre Hospitalier Universitaire Dijon
入组人数
198
试验地点
1
主要终点
presence of conduction disorders on postoperative ECGs
状态
已完成
最后更新
2个月前

概览

简要总结

The incidence of aortic valve disease is increasing steadily because of the ageing of the population. At a certain stage, replacement of the aortic valve improves symptoms and thus the quality of life of patients.

Surgical aortic valve replacement is the " gold standard ". The procedure involves stopping the heart and setting up cardiopulmonary bypass (CPB) to ensure the oxygenation of tissues.

The reference technique consists in suturing a prosthetic valve to the aortic annulus so as to restore normal function. This technique has very good results in the long term. The elective approach is sternotomy, which has certain drawbacks: post-operative pain, risk of infection, psychological trauma of a major incision. In recent years an alternative approach, right minithoracotomy, has been proposed. The drawback to this approach is that it increases aortic cross-clamp time and CPB time.

More recently, new prosthetic valves, so-called "sutureless" or "rapid deployment" valves have become available. The main advantage of these valves is that they are easy to implant, as they do not require or need just a few sutures. As a result heart-arrest time is shorter, post-operative inflammatory syndrome is less frequent and transfusion needs are reduced.

However, these valves have a metallic stent to fix the valve in place by pressing against the aortic annulus, which may give rise to intra-cardiac conduction disorders. Yet, very few studies have been conducted on this subject.

The investigators wish to evaluate these conduction disorders in a cohort of patients operated on in this Department with this sutureless or rapid deployment valve technique.

注册库
clinicaltrials.gov
开始日期
2017年2月16日
结束日期
2022年12月12日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • All patients who underwent implantation of a Suturless valve since 2015 (Intuity Elite Edwards or Perceval S Liva Nova)

排除标准

  • patients with a pacemaker
  • patients who underwent double valve replacement

结局指标

主要结局

presence of conduction disorders on postoperative ECGs

时间窗: through study completion, an average of 2 years

研究点 (1)

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