Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology
研究概览
简要总结
TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. The frequency of this potentially ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this condition is difficult to detect.
The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise for the evaluation of valve leaflet mobility and morphology.
The purpose of this study is in an observational design to assess the frequency of subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon as well as its relation to medical treatment and MACCE will be assessed.
详细描述
MATERIAL In the period from May 2014 to November 2015, a random subset of patients who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) were offered intensified post-procedural clinical and imaging follow-up. It is intended to examine a variety of implanted transcatheter heart valves (THV) as well as surgical aortic valve bioprosthesis.
METHODS:
Post-procedural clinical and imaging follow-up encompasses the following:
- Thoracic 4DCT scanning - with evaluation of leaflet morphology and leaflet motion
- Transthoracic echocardiography - with evaluation of peak aortic valve gradient, mean aortic valve gradient, aortic valve area/effective orifice area (cm2), paravalvular leakage, central aortic valve regurgitation, and left ventricular ejection fraction
- Clinical follow-up: improvement in New York Heart Association (NYHA) class dyspnea, and major adverse cardiac and cerebro-vascular events (MACCE)
- Registration of anti-coagulation/anti-thrombotic therapy following aortic valve replacement
All patients will receive the above-described post-procedural follow-up at two different time-points:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful TAVR or SAVR performed at Rigshospitalet, Copenhagen, Denmark
排除标准
- •renal dysfunction (eGFR <25 ml/min)
- •TAVR-in-TAVR
- •Patients living in Greenland or the Faroe Islands
结局指标
主要结局
Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology
时间窗: At least 21 days post-procedure
次要结局
- Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology(At least 21 days post-procedure)
研究者
Klaus Fuglsang Kofoed
Associated Professor
Rigshospitalet, Denmark